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PubMed2004

Interleukin-2 receptor antagonists and aggressive steroid minimization strategies for kidney transplant patients.

Steroid withdrawal during the first week after transplantation surgery, or complete avoidance of steroids, offers potential benefits. The interleukin-2 (IL-2) receptor antibodies, basiliximab and daclizumab, can enable aggressive steroid minimization protocols that are efficacious while reducing toxicity. A multicenter, randomized trial of kidney transplant recipients has shown the incidence of biopsy-proven acute rejection with basiliximab, cyclosporine and mycophenolate mofetil with steroids withdrawn at day 5 to be similar to a conventional triple-therapy regimen. A single perioperative dose of corticosteroids with an IL-2 receptor antagonist also seems as efficacious as standard steroid therapy. Corticosteroid-minimization with IL-2 receptor antagonists has also been investigated with sirolimus-containing regimens and has shown excellent outcomes. Experience with complete steroid avoidance, using an IL-2 receptor antagonist, is limited, but initial results are promising, particularly in pediatric patients. Administration of an IL-2 receptor antagonist with aggressive steroid minimization in selected, well-monitored patients seems reasonable, but further trials are required to define optimal protocols.

Adrenal Cortex Hormones↗
PubMed2004

Identifying cyclosporine blood levels associated with the prevention of renal transplant rejection: a single-center, randomized prospective study.

Multiple-drug therapy may allow reduced individual drug doses with fewer side effects. Blood levels of cyclosporine (CsA) necessary to avoid rejection may vary with different drug combinations. Fifty-eight kidney transplant patients were randomized into two groups: 25 subjects were assigned to the 4-hour area under the curve (AUC(0-4)) Cohort-the "high arm" (4500 to 5500 ng . h/mL)--1 and 33 to the AUC(0-4) "low arm" (2400 to 3400 ng . h/mL). After CsA introduction, AUC(0-4) was drawn on days 4, 7, 14, 21, 28, 42, 56, 70, 84, 90. We compared the proportion of rejection versus rejection-free patients, according to the CsA exposure. Logistic regression analysis showed that an AUC(0-4) of > or =4000 ng . h/mL or a 2-hour cyclosporine level (C(2)) of > or =1450 ng/mL predicted a rejection-free course among patients not receiving induction therapy. When either basiliximab or thymoglobulin was administered, a C(2) and AUC(0-4) of 1043 +/- 151 ng/mL or 3146 +/- 262 ng . h/mL, respectively, were associated with a rejection-free course. Our findings confirm the need for different CsA levels to prevent rejection according to induction therapy. Induction with either basiliximab or thymoglobulin allows reduced CsA levels during the first 3 months after renal transplantation.

Adult↗
PubMed2005

The cost of steroid-free protocols in primary cadaver kidney transplantation.

Steroid-free immunosuppression regimens have been enjoying recent success in clinical transplantation. The use of antibodies required for such protocols can be an economic burden. We proposed to study their cost in our center. This retrospective study involved 147 consecutive patients subjected to 4 protocols of immunosuppression. The first received triple therapy. The second group received induction with basiliximab, whereas the third received Basiliximab plus cyclosporine (CSA) plus mycophenolate mofetil (MMF), and the fourth received Thymoglobulin plus CSA plus MMF in conjuction with only 4 days of steroid. Rejection episodes were treated with Solumedrol. Six-month charges were obtained from computerized records of the finance department, the in-house laboratories, and the transplantation service registry. All charges were expressed in 2004 dollars. Statistical analyses were obtained using chi-square, analysis of variance (ANOVA) and Kaplan-Meier tests. The 4 groups were similar with regard to donor and/or recipient gender, race, panel reactive antibodies, cold ischemia, dialysis requirements length of stay and readmission, graft survival, and function. Charges were significantly higher in the last 2 groups as compared with triple therapy.

Adult↗
PubMed2005

What is the best immunosuppression in living donor liver transplantation?

INTRODUCTION: As we have learned, there are no golden rules of immunosuppression in solid organ transplantation, and every transplant program is using its own regimen to prevent or treat rejection. We have retrospectively analyzed the incidence and severity of acute rejection in a consecutive series of living donor liver transplants. The major objective during the whole study period was to ultimately avoid any steroids from the beginning. METHODS: Twenty one adult patients and five children received 23 right, one left, and two left lateral lobe grafts from genetically or emotionally related living donors, including four ABO-incompatible pairs. The majority of patients had triple initial immunosuppression, based on tacrolimus, mycophenolate mofetil or sirolimus, and basiliximab or daclizumab. Except methylprednisolone administered before reperfusion in 13 patients, only seven had prednisolone after transplantation, and 12/26 had a completely steroid-free regimen. RESULTS: The overall incidence of biopsy-proven acute rejection was 4/21 in adults (19%) and 4/5 in children (80%). Rejections were mild in five and moderate in three cases, respectively, and easily reversed with steroids in all patients. Different combinations of immunosuppressive drugs or ABO incompatibility did not seem to have an influence on the risk of rejection. CONCLUSION: Despite the small number of patients in this series, completely steroid-free triple-drug immunosuppression with tacrolimus, mycophenolate mofetil, and basiliximab is safe and efficient to prevent acute rejection in adult recipients of living donor liver transplants. At least short-term administration of prednisolone should be considered in pediatric patients.

ABO Blood-Group System↗
PubMed2005

Steroid withdrawal or steroid avoidance in renal transplant recipients: focus on tacrolimus-based immunosuppressive regimens.

Steroid-induced adverse effects after transplantation include cosmetic, metabolic, and cardiovascular complications. Steroid withdrawal or avoidance with cyclosporine-based regimens have been hampered by an unacceptably high rate of acute rejections and increased rates of graft loss. Recently the results of several large, randomized trials of steroid withdrawal/avoidance with tacrolimus-based immunosuppression in renal transplant recipients became available. A review of these trials appeared to be of clinical interest. Data from the THOMAS trial clearly indicate that steroid withdrawal from a regimen of tacrolimus, mycophenolate mofetil (MMF), steroids after 3 months after transplantation is safe with regard to acute rejection rate and graft survival. If an induction therapy with daclizumab is used in combination with tacrolimus and MMF (CARMEN trial), even steroid avoidance is safe with regard to acute rejection rate and graft survival. Finally, in the ATLAS trial, steroid avoidance with basiliximab in combination with tacrolimus (resulting in tacrolimus monotherapy) or alternatively with tacrolimus and MMF both resulted in similar graft survival, but higher rates of acute rejection. In conclusion, steroid withdrawal is safe from a triple-drug regimen of tacrolimus, MMF, and steroids after 3 months after transplantation, and steroid use may completely be avoided with tacrolimus, and MMF combined with daclizumab induction. Tacrolimus monotherapy may be achieved using basiliximab induction at the price of higher rates of acute rejection, but with unaffected graft survival. Thus tacrolimus-based immunosuppression with or without interleukin-2 receptor antagonist induction has made steroid withdrawal or avoidance a realistic option in renal transplantation.

Drug Therapy, Combination↗
PubMed2004

[Renal xenotransplantation from hDAF pig to baboon. Experience and review].

UNLABELLED: The renal xenotransplant could be the solution on the demand of organs for transplantation. We present here our experience and review the actual status of the xenotransplant. METHODS: We have done 20 xenotransplants from transgenic pig h DAF to baboons, with four protocols of immunosuppression. All the hosts were treated with GAS 914. Group A: Cyclophosphamide, Cyclosporine, Mycophenolate, and Steroids (n = 10). Group B: Cyclophosphamide, Cyclosporine, FTY 720, and Steroids (n = 3). Group C: Basiliximab, Cyclosporine, Mycophenolate, and Steroids (n = 3). Group D: Basiliximab, FTY 720, Everolymus, and Steroids (n = 4). RESULTS: The duration of the xenografts ranged between 1 and 31 days. The function of the xenografts in relation to the type of immunosuppression were not significantly different: A) 7 days, B) 8 days, C) 8 days, and D) 9 days. CONCLUSIONS: 1. The cold ischemic time of the graft, has influence in the initial function of the kidneys but not in the evolution and duration of the graft. 2. The hyperacute rejection has been overcome with the utilization of transgenic pigs. The graft failure was due to acute humoral rejection that was not aborted by the actual inmunosupressors. 3. It is necessary to develop new immunosuppression protocols, through new knowledge of their pharmacology and the physiology of the xenografts, and at the same time it is important to avoid the potential risk of transmission of animal infections.

Animals↗
PubMed2005

A multicenter, prospective study of C2-monitored cyclosporine microemulsion in a U.S. population of de novo renal transplant recipients.

BACKGROUND: Monitoring cyclosporine microemulsion (CsA-ME; Neoral) exposure 2 hours postdose (C2) has been reported to optimize the efficacy and safety of CsA-ME therapy. The addition of induction therapy to a maintenance regimen including CsA-ME C2 monitoring has not been evaluated. METHODS: In all, 123 adult renal transplant recipients were recruited at 14 U.S. centers for this 6-month study. CsA-ME dose was to be titrated to attain C2 targets of 1700 and 1500 ng/ml during posttransplant months 1 and 2, respectively. After 2 months, patients were randomized to one of two groups with different, decreasing C2 targets. Basiliximab, mycophenolate mofetil, and corticosteroids completed the study immunosuppression. RESULTS: Of the 119 evaluable patients, 76% were male, 22% African American, and 66% deceased donor recipients. Biopsy-proven acute rejection occurred in 10 patients (9.3%); there were two failed grafts and one death. Serum creatinine and calculated GFR values suggest good renal function, with month 6 medians of 1.5 ng/ml and 67 ml/min/1.73 m. Safety and tolerability assessments revealed no unexpected outcomes. Observed C2 levels were generally lower than protocol targets, particularly in the first weeks posttransplantation. CONCLUSIONS: The striking efficacy and outcomes may have been achieved in this study with lower C2 levels of CsA-ME because of the addition of basiliximab induction.

Acute Kidney Injury↗
PubMed2006

Living related kidney transplantation without calcineurin inhibitors: initial experience in a Mexican center.

We performed a prospective randomized trial comparing sirolimus/mycophenolate mofetil (MMF)/prednisone to cyclosporine/MMF/prednisone and selected induction therapy with basiliximab. Twenty patients received sirolimus (10 mg loading dose followed by 3 mg/m body surface area/day, keeping 24-hr trough levels at 10-15 ng/mL for six months and 5-10 ng/mL thereafter. Twenty-one patients began cyclosporine (4 to 8 mg/kg/day, keeping 12-hour trough levels at 150-300 ng/mL for 6 months and 100-200 ng/mL afterwards). Mean follow up was 15.8 months. One-year patient and graft survival was similar in both groups (>90%). Acute rejection rate was 16.6% in the sirolimus group and 5.2% in the cyclosporine group (P=NS). There were no differences in mean serum creatinine between groups. No patients who received basiliximab and had sirolimus target levels suffered acute rejection at one year. The sirolimus group had significantly higher cholesterol and triglycerides. A calcineurin inhibitor-free regimen using sirolimus produces comparable one-year transplant outcomes in living related kidney transplants compared to a calcineurin inhibitor regimen.

Adolescent↗
PubMed2007

One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients.

Once-daily tacrolimus extended-release formulation (Prograf XL, formerly referred to as MR or MR4) was compared with the twice-a-day tacrolimus formulation (TAC) and cyclosporine microemulsion (CsA), all administered in combination with mycophenolate mofetil (MMF), corticosteroids and basiliximab induction, in a phase 3, randomized (1:1:1), open-label trial in 638 de novo kidney transplant recipients. In combination with MMF and corticosteroids, XL had an efficacy profile comparable to TAC and CsA. XL/MMF and TAC/MMF were statistically noninferior at 1-year posttransplantation to CsA/MMF for the primary efficacy endpoint, efficacy failure (death, graft loss, biopsy-confirmed acute rejection (BCAR) or lost to follow-up). One-year patient and graft survival were 98.6% and 96.7% in the XL/MMF group, 95.7% and 92.9% in TAC/MMF group and 97.6% and 95.7% in CsA/MMF group. The safety profile of XL in comparison with CsA was similar to that observed with TAC in this study and consistent with previously published reports of TAC in comparison with CsA. The results support the safety and efficacy of tacrolimus in combination with MMF, corticosteroids and basiliximab induction, as well as XL as a safe and effective once-daily dosing alternative.

Adolescent↗
PubMed2005

Case of a patient with progressive adult T-cell leukemia/lymphoma treated successfully by reduced-intensity conditioning stem cell transplantation from an HLA-incompatible related donor.

A 61-year-old man with progressive adult T-cell leukemia/lymphoma (ATLL) successfully received reduced-intensity conditioning stem cell transplantation (RIST) without T-cell depletion (TCD) from his HLA-incompatible son, who had negative results for human T-lymphotropic virus type 1 (HTLV-1) (1-locus, 1-allele mismatch in the graft-versus-host [GVH] direction; 2-loci, 1-allele mismatch in the host-versus-graft direction). The preparatory regimen consisted of fludarabine, busulfan, and rabbit antithymocyte globulin. GVH disease (GVHD) prophylaxis consisted of short-term administration of methotrexate, tacrolimus, and methylprednisolone. The patient achieved complete donor chimerism on day 30 after transplantation. On approximately day 50 the patient started to experience steroid-refractory skin GVHD (grade IV), which was successfully managed with basiliximab (anti-CD25 monoclonal antibody) and mycophenolate mofetil (MMF). Serial analysis of HTLV-1 proviral load by quantitative polymerase chain reaction analysis using whole peripheral blood demonstrated undetectable levels from day 90. At the time of this writing the patient had been in complete remission for more than 16 months. The results in this case suggest the potential of non-TCD RIST from an HLA-incompatible relative donor as an alternative source of hematopoietic stem cells even for an elderly patient with advanced ATLL. In addition, basiliximab combined with MMF may be effective for the treatment of steroid-refractory skin GVHD without deteriorating the graft-versus-ATL effect.

B-Lymphocytes↗
PubMed2004

Outcomes of kidney transplants from non-heart-beating deceased donors as reported to the Japan Organ Transplant Network from April 1995-December 2003: a multi-center report.

Between April 1995-December 2003, 1,324 deceased donor kidney transplantations were performed in 139 transplant institutes in Japan. Of these, 45 transplants were from heart-beating and 1,279 transplants were from non-heart-beating deceased donors (NHBDD). Clinical outcomes for the 1,279 recipients of NHBDD kidney transplants were investigated. The overall 5-year patient and graft survival rates were 90% and 72%, respectively. A total of 112 NHBDD kidney grafts never functioned after transplantation and the recipients had to remain on dialysis. The causes of nonfunction were rejection, primary nonfunction, death, thrombosis and others in the order of the incidence. The major causes of graft loss were nonfunction, death, chronic rejection and acute rejection in that order. Major causes of recipient deaths were pneumonia, sepsis and CVA within 12 months, and heart diseases, sepsis, malignancy and pneumonia more than 12 months after transplantation. Kidneys from female donors, donors aged 15 or less or over age 60, donors with extrinsic causes of death other than head trauma, recipients over age 60 and those with diabetic nephropathy as their original disease were found to be at risk for poor graft survival. The lowest and last donor serum creatinine level did not influence the incidence of nonfunction or graft survival. However, graft survival was significantly poorer among recipients of older "expanded" donor kidneys than for recipients of younger grafts. The warm and total ischemia times should be kept shorter than 30 minutes (better 15 minutes), and 12 hours, respectively to minimize the incidence of nonfunction and early graft loss. It is especially important in cases with WIT over 30 minutes that the total ischemia should be kept within 12 hours. Cannulation before cardiac standstill was important to reduce the incidence of nonfunction and achieve high graft survival rates with NHBDD kidneys. The discontinuance of ventilator support also reduced the incidence of graft nonfunction. The combination of CsA or Tacrolimus and MMF as both the induction and maintenance regimen significantly improved graft survival. The use of either anti-T cell antibodies or basiliximab was also associated with significantly better graft survival for NHBDD kidneys. The combination of basiliximab, CsA and MMF resulted in a graft survival rate of 98% at one and 2 years.

Adolescent↗
PubMed2004

Effects of CD25 monoclonal antibody on proliferative and effector functions of alloactivated human T cells in vitro.

Prophylactic treatment with CD25 mAb has led to a significant decrease of acute rejection rates after renal transplantation. However, despite its inhibitory effect on T cell proliferation and effector functions, rejections still occur. To obtain more insight in persistent alloreactivity, we evaluated the effects of the chimeric IgG1kappa CD25 mAb Basiliximab on proliferation and differentiation of alloactivated T cells from healthy individuals in vitro. Moreover, the capacity of other members of the common cytokine-receptor gamma-chain family to overcome the inhibitory effects of CD25 mAb was studied. The CD25 mAb appeared to limit expansion of alloreactive lymphocytes rather than blocking entry into cell cycle, and it did so irrespective of the previous antigen experience of the cells. Both CD4+ and CD8+ alloresponsive lymphocytes showed diminished intracellular expression of IFN-gamma, TNF-alpha, perforin and granzyme B. Remarkably, cytotoxicity was completely abolished. IL-7, IL-15 and IL-21 could bypass the inhibitory effects of the CD25 mAb on both proliferation and cytotoxicity. In conclusion, persistent alloreactivity in the presence of therapeutic concentrations of CD25 mAb may be caused by alloreactive T cells that still produce cytokines that can damage the allograft. In addition, other members of the common cytokine-receptor gamma-chain family can rescue the proliferative and cytotoxic activity of these alloreactive T cells.

Antibodies, Monoclonal↗
PubMed2004

Steroid withdrawal at day 14 after liver transplantation: a double-blind, placebo-controlled study.

Some clinical studies in liver transplantation have recently reported safety advantages and similar acute rejection rates with early steroid withdrawal. The aim of this study was to evaluate the efficacy and safety of an immunosuppressive regimen with steroid withdrawal at day 14. A multicenter, 1-year, comparative, double blind, placebo-controlled study was performed. Patients undergoing a first cadaveric liver transplantation were recruited and all received basiliximab + cyclosporine + intravenous methylprednisolone. Patients without severe postoperative complications were randomized at day 7 to receive a maintenance regimen with Neoral (cyclosporine) + prednisolone (group 1) or without steroids (Neoral + placebo; group 2), after a 7-day blinded oral steroid tapering period. A total of 174 patients were randomized at day 7 (group 1: n = 90; group 2: n = 84). The incidence of biopsy-confirmed and treated acute rejection at 6 months was 38.1% in group 2 vs. 24.4% in group 1 (P = .03) with a trend for a higher incidence of Grade II / III acute rejection (28.6% vs. 18.9%; P = .12). Changes from baseline were similar with regard to metabolic parameters (glycemia, total cholesterol, and triglycerides). A trend toward a better glucose tolerance was observed, as fewer patients received an antidiabetic treatment in the placebo group (2 vs. 10). In conclusion, this first double-blind, placebo-controlled study of steroid withdrawal at day 14 showed a higher incidence of acute rejection, only balanced by a trend of a lower need of antidiabetic treatment.

Adult↗
PubMed2006

Immunosuppression without steroids in liver transplantation is safe and reduces infection and metabolic complications: results from a prospective multicenter randomized study.

BACKGROUND/AIMS: The purpose of this study was to evaluate the efficacy of a steroid-free immunosuppression protocol. METHODS: From 2001 to 2004, 198 liver-transplant patients were randomized to receive immunosuppression with Basiliximab and cyclosporine, with (St Group) or without (NoSt Group) prednisone. The primary end points were acute rejection, and patient and graft survival. The secondary end points were infection, metabolic complications, and hepatitis C-virus recurrence. RESULTS: Overall rejection rate was 15%, with no differences (St: 13% vs NoSt: 18%; P=0.33). Infection rate was similar in both groups (St: 51% vs NoSt: 47%; P=0.56), but diabetic patients in the St Group had a significantly higher rate of bacterial infections (St: 54% vs NoSt: 14%; P=0.005). The six-month protocol biopsies showed hepatitis C recurrence in 90% of patients, without differences between groups. Hypertension was more frequent in the St Group (St: 44% vs NoSt: 25%; P=0.006). De novo diabetes rate was higher in the St Group (month 1: St: 29% vs NoSt: 18%; P=0.06), with higher glycatedHb (5.1+/-1.1 vs 4.4+/-0.8; P=0.002). Six-month survival rates were similar (St: 89% vs NoSt: 94%, P=0.62). CONCLUSIONS: Immunosuppression without steroids is safe and reduces infection and metabolic complications.

Adult↗
PubMed2004

Simulect induction facilitates Neoral-based steroid-free immunosuppression in primary kidney transplant recipients.

This study compares outcomes of kidney transplantation with two distinct induction protocols Basiliximab (Simulect) versus Muromonab (OTK 3) in the setting of cyclosporine (Neoral)-based immunosuppression. Postinduction protocols included either total prednisone avoidance or prednisone sparing versus standard prednisone dosing. Two hundred forty five adult patients receiving kidney transplantation between 1995 and 2000 were included in the study. Treatment in group 1 was OKT 3 + Neoral + adjunct + standard prednisone; group 2, Simulect + Neoral + adjunct + steroid sparing; group 3, Simulect + Neoral + adjunct + no prednisone. The demographics between all groups were similar. The mean (+/- SD) trough cyclosporine levels at 1 month were 276 +/- 128 versus 291 +/- 180 versus 398 +/- 365 (P=.020); at 3 months were 261 +/- 120 versus 280 +/- 152 versus 399 +/- 408 (P=.32); at 12 month were 235 +/- 144 versus 245 +/- 154 versus 234 +/- 132 (P=.96). Creatinine clearance at 1 month was 59 +/- 24 versus 58 +/- 18 versus 47 +/- 23 mL/min (P=.004); at 3 months was 66 +/- 28 versus 62 +/- 22 versus 53 +/- 25 mL/min (P=.007); at 12 months was 68 +/- 38 versus 65 +/- 22 versus 64 +/- 29 mL/min (P=.556). Serum creatinine at 1 month was 1.8 +/- 0.9 versus 1.6 +/- 1.2 versus 2.8 +/- 2.21 mg/dL (P=.005); at 3 months was 1.7 +/- 0.6 versus 1.9 +/- 1.0 versus 2.3 +/- 1.3 mg/dL (P=.007); at 12 months was 1.9 +/- 1.3 versus 2.1 +/- 1.0 versus 2.3 +/- 1.7 mg/dL (P=.179). The incidence of acute rejection within 1 year in the respective groups were 28% versus 15% versus 16%. Therefore, we conclude that using Simulect in transplant recipients results in long-term patient and graft survival similar to those achieved with OKT 3. The use of Simulect resulted in significant reduction in clinical rejection incidence within the first year regardless of steroid use. Thus, the use of Simulect allows complete steroid avoidance in Neoral-based immunosuppression regimen.

Antibodies, Monoclonal↗
PubMedDate not supplied

Calcineurin inhibitor-free immunosuppression in renal transplantation.

PURPOSE: To describe our initial results using a calcineurin inhibitor-free immunosuppression protocol in renal transplants. PATIENTS AND METHODS: Between October 2001 and June 2003, 56 recipients of a renal allografts were started on an immunosuppression protocol without calcineurin inhibitors, consisting of basiliximab, sirolimus, mycophenolate mofetil, and steroids. We analyzed patient and graft survival, acute rejection episodes, and renal function. RESULTS: The mean follow-up was 19.6 months. Actuarial patient survival at 1 and 2 years was 98.1% and 95.3%, respectively. Actuarial graft survival at 1 and 2 years was 92.9% and 87.6%, respectively. Acute rejection occurred in 27.8% of the patients, usually Banff 1 (73.3%). There was stable renal function with mean serum creatinine of 1.3, 1.4, 1.3, and 1.3 mg/dL at 1, 6, 12, and 24 months after transplant. CONCLUSIONS: The use of immunosuppression free of calcineurin inhibitors is effective and safe. Further follow-up is needed to evaluate the impact on long-term results.

Adult↗
PubMedDate not supplied

Neoral versus prograf in simultaneous pancreas-kidney transplantation with portal venous drainage: three-year results of a single-center, open-label, prospective, randomized pilot study.

BACKGROUND: The preferential use of tacrolimus (Prograf) over cyclosporine microemulsion (Neoral) in simultaneous pancreas-kidney transplantation (SPKTx) is mainly based on historical, retrospective studies. We herein report the 3-year results of a single-center, prospective, randomized comparison of the two calcineurin inhibitors in the setting of mycophenolate mofetil (MMF)-based immunosuppression and portal drainage of pancreas allografts. METHODS: Between May 2001 and August 2004, 47 SPKTx recipients who were stratified by recipient sex, were alternatively assigned to treatment with Neoral (n = 22) or Prograf (n = 25). Concurrent immunosuppression included induction treatment with basiliximab and maintenance with MMF and steroids. RESULTS: After a median follow-up of 24.0 months, all patients remained in the study arm into which they were initially enrolled. No pancreas rejection episode was observed. One acute kidney rejection was recorded in the Neoral arm (4.5%) as compared with 7 (28.0%) including one steroid-resistant episode, in the Prograf arm (P = .03). The cumulative incidence of adverse events was 31.8% (n = 7) in the Neoral arm compared with 92.0% (n = 23) in the Prograf arm (P < .0001). One patient died in each study arm. Patient, pancreas, and kidney survivals overlapped at 1- and 3-years posttransplant, namely all 95.4% for the Neoral arm compared with 95.8%, 91.8%, and 95.8%, respectively, for the Prograf arm (P > .05). CONCLUSIONS: We conclude that in MMF-based immunosuppression there is no convincing evidence that Prograf should be preferred to Neoral in SPKTx.

Antibodies, Monoclonal↗
PubMed2005

First living related kidney transplantation results in excellent outcomes for small children.

OBJECTIVE: The aim of this study was to evaluated the outcomes of living related kidney transplantation in small children. MATERIALS AND METHODS: Ten pediatric patients with body weights less than 10 kg received parental kidney transplants (five mothers and five fathers). An intra-abdominal approach was used in nine children and a retroperitoneal approach in one child. Bilateral, left, or right nephrectomy was performed in seven, two, and one child, respectively. Immunosuppression consisted of either cyclosporine (n = 7) or tacrolimus (n = 3) with either mizoribine (n = 4) or mycophenolate mofetil (MMF) (n = 5) or azathioprine (n = 1), and methylprednisolone (n = 10). Antilymphocyte globulin was used in the first series of four children; basiliximab in the most recent five children. RESULTS: All renal allografts functioned immediately after transplantation despite the mismatched size of the large renal allografts. Nine of 10 children were alive with a functional allograft at 6 to 196 months posttransplantation. One child died of intra-abdominal bleeding 5 days posttransplantation. One child has suffered chronic allograft nephropathy 11 years posttransplantation (serum creatinine 3.3 mg/dL). The remaining eight children display good renal function (serum creatinine = 0.2 to 1.43 mg/dL). Steroids were withdrawn in eight of nine children; one child continues on alternative-day therapy. One child (LD55) exceeded the mean standard height. The most recent height standard deviation (SD) scores were superior (-1.75 +/- 1.39 [-3.83 to 0.54]; P < .0082) to those at transplantation (-2.91 +/- 0.79 [-2.00 to -4.14]). CONCLUSIONS: The outcomes of living related kidney transplantation in small children were excellent despite the operative risks and the difficulty of cardiovascular and fluid management. Transplantation for small children appears to result in much better quality of life and growth than dialysis.

Antibodies, Monoclonal↗