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PubMedDate not supplied

Embryotoxic effects of CKD-602, a new camptothecin anticancer agent, in rats.

CKD-602 is a newly developed camptothecin anticancer agent. Preclinical studies suggest that it may have greater antitumor activity and lower toxicity than other camptothecin anticancer agents. The potential of CKD-602 to induce embryotoxicity was investigated in the Sprague-Dawley rat. One hundred mated females (sperm in vaginal lavage=day 0) were distributed among three treatment groups and a control group. CKD-602 was administered intravenously at dose levels of 0, 5, 20 and 80 microg/kg/d to pregnant rats from days 6 to 15 of gestation. The vehicle control rats received an equivalent volume of 1 ml distilled water with d-mannitol 50mg and tartaric acid 0.06 mg. All dams were subjected to the caesarean section on day 20 of gestation. There were no signs of maternal toxicity or embryotoxicity at 5 microg/kg/d, but at 20 microg/kg/d, there was an increase in relative brain weight. At 80 microg/kg/d, reduced food intake, suppressed body weight and increased weight of spleen were observed in dams. An increase in the resorptions and dead fetuses, a decrease in litter size, fetal and placental weights were also found. In addition, various types of external, visceral and skeletal malformations occurred. Characteristic malformations included absent eye bulge, agnathia, dilated cerebral ventricle, anophthalmia, absent thoracic centrum, fused vertebral arch, fused rib, among others. Visceral and skeletal variations were observed. Retarded ossification of several skeletal districts and delayed ossification of sternebrae, metatarsals and sacrocaudal vertebrae were also observed. The results show that CKD-602 is embryotoxic and teratogenic at a minimally maternally toxic dose, i.e. at 80 microg/kg/d in rats. The no-observed-adverse-effect level (NOAEL) of CKD-602 for developmental toxicity was considered to be 20 microg/kg/d, however, the NOAEL for maternal toxicity was 5 microg/kg/d.

Abnormalities, Drug-Induced↗
PubMed2002

Preformulation studies of a novel camptothecin anticancer agent, CKD-602: physicochemical characterization and hydrolytic equilibrium kinetics.

(20S)-7-(2-isopropylamino)ethylcamptothecin.HCl (CKD-602), a new camptothecin (CPT) anticancer agent, is a pale yellowish crystalline compound. DSC thermogram exhibited a melt endotherm near 270 degrees C, and CKD-602 was found to be slightly hygroscopic. The solubility of CKD-602 in deionized water was 8.22 mg/ml, and two pK(a) values were measured to be 2.32 and 9.15, respectively. A pH-dependent partition coefficient behavior in octanol-buffer was observed. CKD-602 in solid state was stable over the range of temperature and humidity, but decomposed slightly by light. The hydrolysis of CKD-602 occurred reversibly and rapidly in aqueous buffer solutions. The conversion rate constants (k(f): from the lactone to the carboxylate and k(r): from the carboxylate to the lactone) and the final equilibrium ratio (K(eq)) between two species were dependent on the pH of aqueous solutions.

Antineoplastic Agents, Phytogenic↗
PubMed2006

An evaluation of a shared primary and secondary care nephrology service for managing patients with moderate to advanced CKD.

BACKGROUND: Chronic kidney disease (CKD) is common, and nephrology services may not cope with the comprehensive referral of patients with CKD. We evaluated a shared primary and secondary care nephrology scheme, hypothesizing that some patients with less progressive moderate to advanced CKD can be identified and safely managed without attending the renal unit. METHODS: A retrospective review of 949 new referrals with stages 3 to 5 CKD managed in either the hospital nephrology clinic (HC) or the shared care scheme (SCS), in which nephrologists review patients remotely by using regular biochemical tests and clinical data recorded in primary care. RESULTS: Two hundred sixty-six patients (28%) were enrolled in the SCS and 683 patients (72%) were managed solely in the HC. Median time to entering the SCS was 111 days (interquartile range, 0 to 328 days). Baseline factors independently predictive of enrollment in the SCS were increasing age, greater glomerular filtration rate (GFR) and serum albumin levels, and no diabetic nephropathy. Few SCS patients did not attend reviews. Forty-one patients (15%) required recall to the HC, mostly because of a decline in GFR. Beneficial changes were seen in blood pressure levels and prescribing of angiotensin-system inhibitors from first referral to 3 years in all patients. Those enrolled in the SCS had good prognosis, with a lower risk for death or renal replacement therapy than the HC group after adjustment for age, sex, GFR, diabetic nephropathy, and vascular disease (hazard ratio, 0.64; 95% confidence interval, 0.38 to 0.89; P = 0.003). CONCLUSION: In this setting, it was possible to select nearly 30% of patients with stages 3 to 5 CKD for management in the SCS. More than half enrolled within 4 months of nephrology referral. Systematic surveillance was effective, and most patients remained stable, with few progressing to renal replacement therapy or death.

Aged↗
PubMed2006

Cardiovascular biomarkers in CKD: pathophysiology and implications for clinical management of cardiac disease.

Cardiovascular disease (CVD) is a major cause of morbidity and mortality in patients with all forms of chronic kidney disease (CKD). The underlying pathological state is caused by a complex interplay of traditional and nontraditional risk factors that results in atherosclerosis, arteriosclerosis, and altered cardiac morphological characteristics. This multifactorial disease introduces new challenges in predicting and treating patients with CVD sufficiently early in the course of CKD to positively alter patient outcome. Asymptomatic individuals with progressive CVD are a group of patients that deserve focused attention because early detection and intervention may provide the best opportunity for improved outcome. However, identifying CVD in asymptomatic patients with CKD or end-stage renal disease remains a significant hurdle in the management of these patients. Recently, a number of cardiovascular biomarkers were identified as predictors of patient outcome in individuals with CVD and, with additional research, may be used to guide the early diagnosis of and therapy for CVD in patients with CKD. This review examines the pathophysiological characteristics and potential clinical role of these novel cardiovascular biomarkers in risk stratification, risk monitoring, and selection of preventive therapies for patients with CKD.

Biomarkers↗
PubMed2003

Safety pharmacology of CKD-602, a novel anticancer agent.

CKD-602 ((20S)-7-[2-(N-isopropylamino)-ethyl]-camptothecin.HCl, CAS 213819-48-8) is a new class of anticancer drug that belongs to the topoisomerase inhibitors. Its effect on the central nervous system (CNS), general behavior, cardiovascular-respiratory system and the other organ systems were studied. When intravenously administered, CKD-602 up to doses of 5 mg/kg caused an increase of body temperature, increase of respiration rate, decrease of gastrointestinal transport, showed analgesic action and produced antisecretory action in pylorus ligated rats. However, CKD-602 showed no effects on general behavior, motor coordination, spontaneous locomotor activity, hexobarbital sleeping time, convulsion, cardiovascular, smooth muscle and urinary tract system. These findings demonstrate that CKD-602 in doses up to 5 mg/kg has minor effects on the CNS in animals. However, CKD-602 does not exert any general pharmacological effects at the dose of 1 mg/kg except the effects on gastric secretion.

Analgesics↗
PubMed2005

Effects of CKD-602, a new camptothecin anticancer agent, on pregnant does and embryo-fetal development in rabbits.

CKD-602 is a newly developed camptothecin anticancer agent. Preclinical studies suggest that it may have greater antitumor activity and lower toxicity than other camptothecin anticancer agents. The potential of CKD-602 to induce developmental toxicity was investigated in the New Zealand White rabbit. Seventy-two artificially inseminated females (artificial insemination=day 0) were distributed among three treatment groups and a control group. CKD-602 was at dose levels of 0, 0.024, 0.048, or 0.096 mg x kg(-1) x day(-1) administered intravenously to pregnant does from days 6 to 18 of gestation. All does were subjected to caesarean section on day 28 of gestation. At 0.096 mg x kg(-1) x day(-1), 2 cases of abortion and 3 cases of death in pregnant rabbits were found in late gestation. In addition, an increase in the embryonic resorptions and a decrease in the litter size were found. At 0.048 mg x kg(-1) x day(-1), a single doe aborted on gestational day 26. An increase in the embryonic resorptions and fetal morphological alterations and a decrease in the litter size were also found. There were no signs of maternal toxicity or developmental toxicity at 0.024 mg x kg(-1) x day(-1). The results show that 13-day repeated intravenous dose of CKD-602 during the major organogenetic period in rabbits produces increased incidence of abortion and death, increased number of embryonic resorptions and fetal morphological alterations, and decreased litter size at dose levels of above 0.048 mg x kg(-1) x day(-1). In the current experimental conditions, the no-observed-adverse-effect levels (NOAELs) of CKD-602 are considered to be 0.048 mg x kg(-1) x day(-1) for does and 0.024 mg x kg(-1) x day(-1) for embryo-fetal development.

Abnormalities, Drug-Induced↗
PubMed2003

Impact of vitamin E on plasma asymmetric dimethylarginine (ADMA) in chronic kidney disease (CKD): a pilot study.

BACKGROUND: Asymmetric dimethylarginine (ADMA), an endogenous inhibitor of endothelial nitric oxide synthase and a proposed cardiovascular risk factor, is elevated in chronic kidney disease (CKD). Pharmacological strategies that lower plasma concentration of ADMA may be expected to increase nitric oxide (NO.) bioavailability and potentially limit atherosclerosis. We hypothesized that the antioxidant alpha-tocopherol (vitamin E) reduces ADMA levels in CKD. METHODS: An open-label pilot interventional study using 800 IU of vitamin E was undertaken in eight stable out-patients with non-diabetic CKD (creatinine clearance <30 ml/min/1.73 m(2)) and six healthy controls, with the objective of measuring plasma ADMA levels at baseline and after 8 weeks of treatment. Plasma ADMA, symmetric dimethylarginine (SDMA) and alpha-tocopherol concentrations were determined at study entry and exit using high-performance liquid chromatography, while plasma total F2-isoprostanes, an index of oxidative stress, were measured using a commercially available enzyme-linked immunosorbent assay kit. RESULTS: ADMA and SDMA concentrations were significantly higher in the plasma of patients compared with that of controls (P </= 0.001). After treatment with vitamin E, ADMA decreased by 23% in six of eight patients (P <0.001). The remaining two patients showed either an increase or no change (overall, P = 0.16). There was no significant change in plasma F2-isoprostanes with vitamin E treatment for 8 weeks. CONCLUSIONS: Antioxidant therapy with vitamin E has the potential to lower ADMA levels in CKD patients, implying increased NO. availability. This strategy merits further exploration in the setting of CKD prior to renal replacement.

Adult↗
PubMed2002

The identification of in vitro metabolites of CKD-732 by liquid chromatography/tandem mass spectrometry.

The structural elucidation of fourteen metabolites of CKD-732, formed in vitro with rat liver microsomes, was performed using high-performance liquid chromatography/electrospray ionization-tandem mass spectrometry (HPLC/ESI-MS/MS). To identify proposed structures of the metabolites, the product ion mass spectra of the protonated molecules ([M + H]+), the retention times on reversed-phase HPLC, and UV-Vis spectra were utilized. Characteristic product ions for the identification of CKD-732 metabolites were observed at m/z 231, 236, and 252. The fragment ions at m/z 236 and 252 indicated the unchanged form and the N-oxide of the dimethylaminoethoxycinnamoyl group, respectively. The ion at m/z 231 indicated the presence of the hydroxylated form of the fumagillol group. The N-oxide of CKD-732, which was detected at m/z 515 and eluted later than CKD-732 in the reversed-phase HPLC system, was measured as a major metabolite. Three cis-trans isomers were also found.

Animals↗
PubMed2006

Reproductive toxicity evaluation of a new camptothecin anticancer agent, CKD-602, in pregnant/lactating female rats and their offspring.

CKD-602 is a camptothecin anticancer agent that was recently developed by the Chong Kun Dang Pharmaceutical Co. (Seoul, Korea). This study examined the potential adverse effects of CKD-602 on pregnancy, delivery, and lactation in female Sprague-Dawley rats as well as on the pre- and postnatal development of their offspring. One hundred pregnant females were divided into four groups: three treatment groups and a control group. CKD-602 was administered once daily by intravenous bolus injection to female rats at doses of 0, 5.7, 17, or 51 microg/kg/day from gestational day 6, through to parturition and throughout the period of lactation up to weaning [lactational day (LD) 21]. All the dams were sacrificed on LD 22 after weaning. The clinical signs, mortality, body weight change, food consumption, physical development, and behavioral function were evaluated in their progeny. When the exposed offspring reached maturity (postnatal day 70), their reproductive performance was assessed. In the high-dose group, suppressed body weight and a decrease in the amount of food consumption were observed in the dams during both the gestation and lactation periods. An increase in the incidence of thymic atrophy, decreased liver and ovary weight, and an increase in the weight of the spleen were also observed in the dams at the scheduled necropsy. In addition, an increase in the number of stillborn and postnatal mortality, a decrease in the live litter size, and a delay in physical development were observed in the F1 offspring. Teratological examinations showed an increase in the incidence of congenital anomalies in both the F1 offspring and F2 fetuses. In the medium dose group, only slight maternal toxicity including suppressed body weight and decreased food consumption was observed. There were no treatment-related effects on the maternal function and pre- and postnatal development in the low dose group. The no-observed-adverse-effect level (NOAEL) of CKD-602 for the dams are considered to be 5.7 microg/kg/day, however, the NOAEL for their offspring are estimated to be 17 microg/kg/day.

Abnormalities, Drug-Induced↗
PubMed2005

Outcomes after percutaneous coronary interventions in patients with CKD: improved outcome in the stenting era.

BACKGROUND: Percutaneous coronary intervention (PCI) with stenting reduces adverse events in the general population compared with balloon angioplasty. The benefit of stents in high-risk patients normally excluded from clinical trials has not been well studied. Outcomes after PCIs in patients with chronic kidney disease (CKD) before and after widespread use of stents were compared. METHODS: All patients undergoing PCIs at our center within 2 periods selected for high and low stent use were included. Demographic, kidney and cardiac function, and PCI data were collected. Kaplan-Meier curves were constructed, and Cox proportional hazards analysis was used to assess the effect of high stent use on major adverse cardiac event, a composite of cardiac revascularization, myocardial infarction, or death 3 years after PCI. RESULTS: A total of 1,879 patients (780 patients, low stent use; 1,099 patients, high stent use; 18% and 94.1% stent use, respectively) with a mean age of 63 years, 73% men, and 26% of patients with a glomerular filtration rate less than 60 mL/min were included. At baseline, there was a greater prevalence of severe CKD, cardiac risk factors, and cardiovascular disease in the high-stent-use cohort. Major adverse cardiac events were reduced in the contemporary cohort (hazard ratio, 0.61; 95% confidence interval, 0.52 to 0.72); this benefit extended across all stages of kidney function. CONCLUSION: Patients with CKD undergoing PCI in the stenting era show improved outcomes. Additional studies are needed to determine optimal revascularization strategies in patients with CKD.

Aged↗
PubMed2005

Prevalence of calcidiol deficiency in CKD: a cross-sectional study across latitudes in the United States.

BACKGROUND: Recent Kidney Disease Outcomes Quality Initiative guidelines have raised concerns of 25-hydroxyvitamin D, or calcidiol, insufficiency and deficiency in patients with chronic kidney disease (CKD) not yet on dialysis therapy; however, no cross-sectional study across latitudes has been performed to support this assertion. METHODS: Baseline screening data from a prospective study were used to determine calcidiol levels in subjects with moderate to severe CKD not yet on dialysis therapy from 12 geographically diverse regions of the United States. Calcidiol deficiency is defined as levels less than 10 ng/mL (< 25 nmol/L), and insufficiency, as levels of 10 to 30 ng/mL (25 to 75 nmol/L). RESULTS: Two hundred one subjects with a mean age 65 +/- 13 years and calculated glomerular filtration rate (GFR) of 27 +/- 11 mL/min (0.45 mL/s) were evaluated. Overall mean calcidiol level was 19.4 +/- 13.6 ng/mL (48 +/- 34 nmol/L), with a range of 0 to 65 ng/mL (0 to 162 nmol/L). Only 29% and 17% of subjects with moderate and severe CKD had sufficient levels, respectively. Mean calcidiol levels were less than sufficient levels in all geographic locations tested. Multivariate analysis found log calcidiol level correlated with calcium level (P = 0.016), log calcitriol level (P = 0.024), sex (P = 0.041), geographic location (P = 0.045), and inverse intact parathyroid hormone level (P = 0.013), but not calculated GFR or phosphorous level. Calcidiol levels changed modestly in 18 patients who had calcidiol levels measured in winter and late summer after confirmed exposure to sunlight, with mean calcidiol levels of 17.9 +/- 11.7 to 21.2 +/- 10.0 ng/mL (45 +/- 29 to 53 +/- 25 nmol/L; P = 0.015). CONCLUSION: This cross-sectional cohort study found a high prevalence of calcidiol deficiency and insufficiency in patients with moderate and severe CKD not on dialysis therapy regardless of geographic location.

Adult↗
PubMed2005

Antagonists of aldosterone and proteinuria in patients with CKD: an uncontrolled pilot study.

BACKGROUND: Experimental evidence suggests that aldosterone may contribute to progressive kidney disease. Although angiotensin-converting enzyme (ACE) inhibitors and angiotensin type 1 receptor antagonists (ARBs) suppress the renin-angiotensin system, these agents do not adequately control plasma aldosterone levels. Hence, administration of aldosterone receptor antagonists may provide additional renal benefits to the ACE inhibitors and ARBs. METHODS: In the present uncontrolled pilot study, we evaluate the short-term (8 weeks) effects of spironolactone on proteinuria in 42 patients with chronic kidney disease (CKD) already treated with ACE inhibitors and/or ARBs. RESULTS: Spironolactone (25 mg/d for 8 weeks) decreased proteinuria from protein of 2.09 +/- 0.16 to 1.32 +/- 0.08 g/24 h after 2 weeks and 1.05 +/- 0.08 g/24 h after 8 weeks. Four weeks after discontinuation of spironolactone therapy, proteinuria returned to close to baseline values. Baseline proteinuria correlated significantly with plasma aldosterone level (r = 0.81; P < 0.0001). Moreover, baseline aldosterone level correlated significantly with degree of reduction in proteinuria after treatment with spironolactone (r = 0.70; P < 0.0001). Spironolactone caused a significant increase in serum potassium levels (from 4.4 +/- 0.1 mEq/L [mmol/L] at baseline to 4.8 +/- 0.1 mEq/L [mmol/L] after 8 weeks of treatment; P < 0.01). CONCLUSION: This study shows that spironolactone may effectively reduce proteinuria in patients with CKD. Concerns remain in regard to the risk for hyperkalemia in patients with CKD. Prospective randomized trials are necessary to confirm the efficacy and safety of antagonists of aldosterone on proteinuria and progression of CKD.

Angiotensin II Type 1 Receptor Blockers↗
PubMed2005

Cinacalcet hydrochloride is an effective treatment for secondary hyperparathyroidism in patients with CKD not receiving dialysis.

BACKGROUND: Secondary hyperparathyroidism develops early in patients with chronic kidney disease (CKD). Clinical guidelines from the National Kidney Foundation-Kidney/Disease Outcomes Quality Initiative emphasize the need to control parathyroid hormone (PTH), calcium, and phosphorus levels in patients with CKD not receiving dialysis to reduce poor outcomes. This phase 2 study evaluated the effects of the oral calcimimetic cinacalcet hydrochloride in patients with CKD not on dialysis therapy. METHODS: A randomized, double-blind, placebo-controlled, 18-week study enrolled adults with an estimated glomerular filtration rate of 15 to 50 mL/min/1.73 m2 (0.25 to 0.83 mL/s/1.73 m2) and an intact PTH (iPTH) level greater than 130 pg/mL (ng/L). Cinacalcet (or placebo) was titrated from 30 to 180 mg once daily to obtain a 30% or greater reduction in iPTH levels from baseline. RESULTS: Baseline mean iPTH levels were 243 pg/mL (ng/L) in the cinacalcet group (n = 27) and 236 pg/mL (ng/L) in the control group (n = 27). At baseline, 28% of subjects were being administered vitamin D sterols and 43% were being administered phosphate binders or calcium supplements. The addition of cinacalcet significantly decreased iPTH concentrations compared with controls during the efficacy-assessment phase: 56% versus 19% of subjects achieved a 30% or greater reduction in iPTH levels (P = 0.006), and mean iPTH levels decreased by 32% in the cinacalcet group, but increased by 6% in the control group (P < 0.001). Mean serum calcium and phosphorus levels remained within normal range throughout the study. Cinacalcet generally was well tolerated; the most frequent adverse events were gastrointestinal. CONCLUSION: This preliminary study provides evidence that cinacalcet is efficacious for the treatment of secondary hyperparathyroidism in subjects with CKD not receiving dialysis.

Calcium↗
PubMed2005

Predialysis psychoeducational intervention extends survival in CKD: a 20-year follow-up.

BACKGROUND: Predialysis psychoeducational interventions increase patient knowledge about chronic kidney disease (CKD) and its treatment and extend time to dialysis therapy without compromising physical well-being in the short run. The present research examines long-term survival after predialysis psychoeducational intervention. In addition, we examined whether survival differed because of early (ie, > or = 3 months) versus late referral to nephrology. METHODS: We collected follow-up data for patients with CKD who participated in a multicenter randomized controlled trial of predialysis psychoeducational interventions in the mid-1980s. We gathered 20-year survival data from clinical records and databases. RESULTS: Participants included 335 patients with CKD, including 172 patients randomly assigned to receive predialysis psychoeducational interventions (63.0% men; mean age, 50.8 years) and 163 patients assigned to usual care (62.1% men; mean age, 52.7 years). Two hundred forty-six patients (66.8%) died during the course of the study. Mean duration of follow-up was 8.5 +/- 7.23 (SD) years. Analyses were by intention to treat. Adjusting for age, general nonrenal health at inception, and time between identification and predialysis psychoeducational intervention or usual care, Cox proportional hazards multiple regression analyses indicated that median survival was 2.25 years longer after patients with CKD received predialysis psychoeducational interventions compared with usual care (chi-square-change [1] = 3.75; P = 0.053; hazard ratio, 1.32; 95% confidence interval, 1.0 to 1.74). Predialysis psychoeducational intervention recipients survived a median of 8.0 months longer than usual-care patients after the initiation of dialysis therapy (chi-square-change [1] = 4.39; P = 0.036; hazard ratio, 1.35; 95% confidence interval, 1.02 to 1.775). No significant survival advantage was evident for early referral to nephrology or the combination of early referral plus predialysis psychoeducational interventions. CONCLUSION: Predialysis psychoeducational intervention is a safe and useful intervention that contributes valuably to multidisciplinary predialysis care.

Aged↗
PubMed2006

Paricalcitol capsule for the treatment of secondary hyperparathyroidism in stages 3 and 4 CKD.

BACKGROUND: The safety and efficacy of paricalcitol injection have been well established for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 5. The capsule form of paricalcitol was developed to provide a convenient dosage form for patients with stages 3 and 4 CKD. METHODS: Three randomized, placebo-controlled, phase-3 trials were conducted in patients with stages 3 and 4 CKD with SHPT. Enrollment criteria included an estimated glomerular filtration rate between 15 and 60 mL/min/1.73 m2 (0.25 and 1.00 mL/s/1.73 m2), an average of 2 consecutive intact parathyroid hormone (iPTH) levels greater than 150 pg/mL (ng/L), 2 consecutive serum calcium levels between 8.0 and 10.0 mg/dL (2.00 and 2.50 mmol/L), and 2 consecutive serum phosphorus levels of 5.2 mg/dL or less (< or = 1.68 mmol/L). Two studies used a thrice-weekly dosing regimen and 1 study used a once-daily dosing regimen for 24 weeks. Dosing was based on serum iPTH, calcium, and phosphorus levels. The primary efficacy end point is 2 consecutive decreases in iPTH levels greater than 30% from baseline. RESULTS: Two hundred twenty patients participated (n = 107, paricalcitol; n = 113, placebo). At least 2 consecutive decreases in iPTH levels of 30% or greater from baseline occurred in 91% of paricalcitol versus 13% of placebo patients (P < 0.001). Incidences of hypercalcemia, hyperphosphatemia, and elevated calcium-phosphorus product levels were not significantly different between groups. Similarly, no significant differences in urinary calcium and phosphorus excretion or deterioration in kidney function were detected in patients administered paricalcitol compared with placebo. CONCLUSION: Paricalcitol capsule was well tolerated and effectively decreased iPTH levels with minimal or no impact on calcium levels, phosphorus balance, and kidney function in patients with stages 3 and 4 CKD.

Adult↗
PubMed2006

Attitudes of Canadian nephrologists toward multidisciplinary team-based CKD clinic care.

BACKGROUND: Although evidence supporting the advantages of multidisciplinary team-based chronic kidney disease (CKD) care is not well developed, many groups are advocating increased availability of this model. METHODS: The research design is a mailed survey sent to 523 members of the Canadian and Quebec Societies of Nephrology. RESULTS: After excluding 113 respondents who declared themselves to be ineligible, the response rate was 54%. Ninety-one percent of nephrologists reported that they usually or always use a CKD clinic. Decisions about when to perform CKD-related tasks were based mainly on an estimate of glomerular filtration rate, rather than time remaining before end-stage renal disease (ESRD). The ideal creatinine clearance for referral to a CKD clinic was 30 to 59 mL/min (0.50 to 0.98 mL/s), but the usual level was 20 to 29 mL/min (0.33 to 0.44 mL/s). The ideal time for referral was more than 12 months before ESRD. Renal replacement therapy discussions were initiated at a creatinine clearance of 20 to 29 mL/min (57%). Nephrologists supported promotion of home dialysis for suitable patients, but not mandating this. Nephrologists did not provide a blunt prognosis to patients who did not specifically ask. Late referral based on adequate time for ESRD preparation was reported to be 4 to 6 months (27%), 7 to 9 months (26%), or 10 to 12 months (30%). Thirty-eight percent said that optimal preparation takes 13 months or longer. CONCLUSION: The literature's common definition of less than 3 months as a cutoff value between late and early referral is not endorsed. Given that multidisciplinary team-based care is widely available in Canada, this study might inform other jurisdictions about the merits and problems associated with multidisciplinary team-based care and might shape the agenda for future empirical research.

Attitude of Health Personnel↗
PubMed2006

Facilitated process improvement: an approach to the seamless linkage between evidence and practice in CKD.

BACKGROUND: Two common strategies for guideline implementation are preformed practice improvement tools, such as flowcharts, and process reengineering by total quality management (TQM) teams. Prespecified tools fail to accommodate local circumstances, TQM requires an unrealistic level of local commitment, and neither has a proven track record for success. METHODS: We describe an alternative approach termed facilitated process improvement (FPI), a systematic exploration of potential modifications to systems of care, and its application to the implementation of an evidence-based chronic kidney disease (CKD) guideline, focusing on individuals not yet requiring renal replacement therapy. The FPI steps followed by the implementation work group to develop a set of implementation tools for the Renal Physicians Association Advanced CKD Guideline included: (1) developing functional specifications of processes, including actions and prerequisites required; (2) investigating processes of care in a variety of site types to understand processes and reasons for failures; (3) developing practical tools corresponding to root causes of failures of processes and subprocesses; and (4) developing a meta-tool to tailor local selection of tools. RESULTS: Formal needs assessment identified processes of care related to 3 major tasks: identify patients, develop and communicate patient-specific management plan, and implement plan. Subtasks were identified to address root causes of failures, and, for each, tools were modified from existing or developed de novo by the work group, which further developed an organized management approach that uses 4 categories of tools: (1) assessment tools identify opportunities for improvements; (2) tailoring tools, a unique feature of this approach, determine which tools are applicable; (3) implementation tools identify patients and communicate and implement management plan; and (4) evaluation tools assess the impact of implementation. CONCLUSION: The work group, in collaboration with community clinicians, patients, and CKD and tool experts, developed and used FPI to provide a range of tools in a fashion that supports and simplifies local assessment, tailoring, implementation, and evaluation. With the formative work completed, practitioners whose practice improvement experience level and other resources may be limited will find it more feasible and practical to provide optimal advanced CKD management without the demands of conventional TQM or continuous quality improvement.

Chronic Disease↗
PubMed2006

Obesity, smoking, and physical inactivity as risk factors for CKD: are men more vulnerable?

BACKGROUND: The incidence of end-stage renal disease is especially high in men, and some studies indicated that smoking is a risk factor for men only. We investigated associations between obesity, smoking, and physical inactivity and chronic kidney disease (CKD) in the general population and whether risk for CKD was restricted to men. METHODS: This was a cross-sectional health survey of the entire adult population of Nord-Trondelag County, Norway, 1995 to 1997, with a 70.6% participation rate. Glomerular filtration rate (GFR) was estimated in all subjects 20 years and older from calibrated serum creatinine levels by using the simplified Modification of Diet in Renal Disease Study formula, and CKD cases are defined as those with a GFR less than 45 mL/min/1.73 m2 (< 0.75 mL/s). RESULTS: A total of 30,485 men and 34,708 women were included, and prevalences of GFR less than 45 mL/min/1.73 m2 (< 0.75 mL/s) were 0.8% and 1.1%, respectively. Age- and sex-adjusted logistic regression analyses showed dose-response relations for body mass index, smoking history, and physical activity. Relative risks were 1.77 (95% confidence interval [CI], 1.47 to 2.14) for obesity (body mass index > or = 30 kg/m2), 1.52 (95% CI, 1.13 to 2.06) for smoking (> 25 pack-years), and 2.14 (95% CI, 1.39 to 3.30) for physical inactivity (no or some physical activity in leisure time). For subjects with all these risk factors, relative risk was 5.10 (95% CI, 2.36 to 11.01). These results remained significant after adjusting for other known risk factors. No biological interactions between sex and obesity, smoking, or physical activity were found. CONCLUSION: Obesity, smoking, and physical inactivity were associated significantly with CKD. Men were not more susceptible to these risk factors than women.

Aged↗