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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 years
- Source :
- Transplantation. 72(2)
- Publication Year :
- 2001
-
Abstract
- A previous report described the 1-year results of a prospective, randomized trial designed to investigate the optimal combination of immunosuppressants in kidney transplantation. Recipients of first cadaveric kidney allografts were treated with tacrolimus+mycophenolate mofetil (MMF), cyclosporine oral solution (modified) (CsA)+MMF, or tacrolimus+azathioprine (AZA). Results at 1 year revealed that optimal efficacy and safety were achieved with a regimen containing tacrolimus+MMF. The present report describes results at 2 years.Two hundred twenty-three recipients of first cadaveric kidney allografts were randomized to receive tacrolimus+MMF, CsA+MMF, or tacrolimus+AZA. All regimens contained corticosteroids, and antibody induction was used only in patients who experienced delayed graft function. Patients were followed up for 2 years.The results at 2 years corroborate and extend the findings of the previous report. Patients randomized to either treatment arm containing tacrolimus experienced improved kidney function. New-onset insulin dependence remained in four, three, and four patients in the tacrolimus+MMF, CsA+MMF, and tacrolimus+AZA treatment arms, respectively. Furthermore, patients with delayed graft function/acute tubular necrosis who were treated with tacrolimus+MMF experienced a 23% increase in allograft survival compared with patients receiving CsA+MMF (P=0.06). Patients randomized to tacrolimus+MMF received significantly lower doses of MMF compared with those administered CsA+MMF.All three immunosuppressive regi-mens provided excellent safety and efficacy. How-ever, the best results overall were achieved with tacrolimus+MMF. The combination may provide particular benefit to kidney allograft recipients who develop delayed graft function/acute tubular necrosis. Renal function at 2 years was better in the tacrolimus treatment groups compared with the CsA group.
- Subjects :
- Adult
Graft Rejection
Time Factors
Adolescent
Administration, Oral
Black People
Kidney Function Tests
Tacrolimus
White People
Postoperative Complications
Azathioprine
Cadaver
Diabetes Mellitus
Humans
Insulin
Child
Antilymphocyte Serum
Cross-Over Studies
Graft Survival
Kidney Tubular Necrosis, Acute
Mycophenolic Acid
Kidney Transplantation
Tissue Donors
United States
Survival Rate
Cyclosporine
Drug Therapy, Combination
Drug Monitoring
Immunosuppressive Agents
Subjects
Details
- ISSN :
- 00411337
- Volume :
- 72
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Transplantation
- Accession number :
- edsair.pmid..........4bb5cb9842e34cc86bfccd75d88c55ac