Randomized Trial of Tacrolimus Plus Mycophenolate Mofetil or Azathioprine Versus Cyclosporine Oral Solution (Modified) Plus Mycophenolate Mofetil After Cadaveric Kidney Transplantation: Results at 2 Years1

Ahsan, Nasimul; Johnson, Christopher P.; Gonwa, Thomas A.; Halloran, Philip F.; Stegall, Mark D.; Hardy, Mark A.; Metzger, Robert A.; Shield, Charles F.; Rocher, Leslie L.; Scandling, John D.; Sorensen, Jeffrey; Mulloy, Laura L.; Light, Jimmy A.; Corwin, Claudia; Danovitch, Gabriel M.; Wachs, Michael; VanVeldhuisen, Paul; Salm, K.; Tolzman, D.; Fitzsimmons, William E.

doi:10.1097/00007890-200107270-00014

Cited by 130 publications

(64 citation statements)

References 18 publications

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“…However, the adverse event defined as an increase in serum creatinine levels seemed to be lower in the group of patients who received tacrolimus in combination with 2 g/d MMF (25.9%) than in patients who were treated with azathioprine (40.7%) or 1 g/d MMF (39%), although this difference did not reach statistical significance. Again, a multicenter trial that tested tacrolimus/MMF versus tacrolimus/azathioprine versus CsA-microemulsion/MMF, did not show statistical differences between the two tacrolimus-treated groups regarding renal function (17)(18)(19). However, both groups exhibited a better renal function in terms of serum creatinine than the group of patients who received CsA-microemulsion/MMF.…”

Section: Renal Functionmentioning

confidence: 92%

“…Tacrolimus/MMF association has not offered apparent advantages on BP control in comparison with dual therapy or triple therapy with steroids/tacrolimus/azathioprine or steroids/CsA/MMF, although detailed data are not available in several studies (15)(16)(17)(18)(19). However, tacrolimus/MMF combination has been tested as a steroid-sparing strategy after kidney transplantation in selected low-risk patients.…”

Section: Arterial Hypertensionmentioning

confidence: 99%

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Impact of Tacrolimus and Mycophenolate Mofetil Combination on Cardiovascular Risk Profile after Kidney Transplantation

Morales¹,

Domínguez‐Gil²

2006

Journal of the American Society of Nephrology

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Section: Renal Functionmentioning

confidence: 92%

Section: Arterial Hypertensionmentioning

confidence: 99%

Impact of Tacrolimus and Mycophenolate Mofetil Combination on Cardiovascular Risk Profile after Kidney Transplantation

Morales¹,

Domínguez‐Gil²

2006

Journal of the American Society of Nephrology

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“…Recently, the introduction of newer, more immunosuppressive MI Ω myocardial infarction CHF Ω congestive heart failure DVT Ω deep vein thrombosis PE Ω pulmonary embolism CMV Ω cytomegalovirus agents (tacrolimus, MMF, microemulsion cyclosporine, rapamycin) allows an overall reduction in early rejection episodes. With these agents in a noninduction regimen, some studies have reported a rejection rate of 15% or less (20,21,28). To this end we have shown that the coadministration of these newer immunosuppressive agents and the limited dosing (a single 5 mg intraoperative dose) of induction agents (e.g.…”

mentioning

confidence: 92%

Limited Dose Monoclonal IL‐2R Antibody Induction Protocol after Primary Kidney Transplantation

Ahsan

Holman

Jarowenko

et al. 2002

American Journal of Transplantation

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This study prospectively compared immunoprophylaxis with a single intraoperative dose (2 mg/kg) of monoclonal interleukin-2 receptor (IL-2R) antibody vs. noninduction in kidney transplant recipients treated with tacrolimus (FK 506), mycophenolate mofetil (MMF) and a prednisone-based immunosuppression regimen. One hundred recipients of first-kidney transplant were enrolled into the study to receive either anti-IL-2R monoclonal antibody, daclizumab (2 mg/kg intraoperatively, limited anti-IL-2R) or no induction (control). Each patient also received oral tacrolimus (dosed to target trough level 10-15 ng/mL), MMF (500 mg bid) and prednisone. The primary efficacy end-point was the incidence of biopsy proven acute rejection during the first 6 months post-transplant. The patients were also followed for 12-month graft function, and graft and patient survival rates. Other than the donor's age being significantly lower in the control group, both groups were comparable with respect to age, weight, gender, race, human leukocyte antigen (HLA)-DR mismatch, panel reactive antibody (%PRA), cold ischemic time, cytomegalovirus (CMV) status, causes of renal failure, and duration and modes of renal replacement therapy (RRT). During the first 6 months, episodes of first biopsy confirmed acute rejection was 3/50 (6%) in the limited anti-IL-2R group and 8/50 (16%) in the controls (p ∞ 0.05). Twelve-month patient 100/98 (%) and graft survival 100/96 (%) were not statistically different. The group receiving limited anti-IL-2R did not have any adverse reactions. Our study demonstrates that a limited (single) 2 mg/kg immunoprophylaxis dose with monoclonal IL-2R antibody (daclizumab) when combined with tacrolimus/ MMF/steroid allows significant reduction in early renal allograft rejection to the single digit level. The therapy with anti-IL-2R antibody is simple and is well tolerated.

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“…At this juncture, it is worth contrasting the differences in renal function noted with the Rapa/MMF regimen by Larson et al (99) with that reported by Flechner et al (97) The CsA/MMF comparator in the study of Flechner et al could well have tilted their results toward inferior renal function as studies do suggest that the CsA/MMF combination may be associated with slightly inferior allograft function compared with the TAC/ MMF combination (101).…”

Section: Cni Avoidance With Rapa/mmf/prednisonementioning

confidence: 97%

Minimizing Immunosuppression, an Alternative Approach to Reducing Side Effects

Srinivas¹,

Meier‐Kriesche²

2008

Clinical Journal of the American Society of Nephrology

122

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Exceptionally low acute rejection rates and excellent graft survival can be achieved with cyclosporine and tacrolimus (CNI)-based immunosuppressive protocols that incorporate antiproliferative immunosuppressants and corticosteroids. However, despite short-term success, long-term attrition of graft function and side effects of immunosuppressive agents continue to be significant problems, leaving clinicians looking for possible interventions. CNI nephrotoxicity is but one of numerous factors that may contribute to long-term damage in transplant kidneys. Metabolic, cosmetic, and neuropsychiatric complications of steroids affect quality of life after transplantation. Newer immunosuppressive agents such as mycophenolate mofetil and sirolimus (Rapa) have raised the possibility of withdrawing or avoiding CNIs or steroids altogether. In this report we review studies that address either CNI or steroid minimization strategies and discuss their risks versus benefits. Given the accumulated experience to date, in our opinion the use of CNIs and steroids as part of immunosuppressive regimens remains the proven standard of care for renal transplant patients. The long-term safety and efficacy of CNI and steroid minimization strategies needs to be further validated in controlled clinical trials with adequate long-term follow-up.

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Randomized Trial of Tacrolimus Plus Mycophenolate Mofetil or Azathioprine Versus Cyclosporine Oral Solution (Modified) Plus Mycophenolate Mofetil After Cadaveric Kidney Transplantation: Results at 2 Years1

Cited by 130 publications

References 18 publications

Impact of Tacrolimus and Mycophenolate Mofetil Combination on Cardiovascular Risk Profile after Kidney Transplantation

Impact of Tacrolimus and Mycophenolate Mofetil Combination on Cardiovascular Risk Profile after Kidney Transplantation

Limited Dose Monoclonal IL‐2R Antibody Induction Protocol after Primary Kidney Transplantation

Minimizing Immunosuppression, an Alternative Approach to Reducing Side Effects

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