Journal article
Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mycophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation
Transplantation, Vol.69(5), pp.834-841
03/15/2000
DOI: 10.1097/00007890-200003150-00028
PMID: 10755536
Abstract
Our clinical trial was designed to investigate the optimal combination of immunosuppressants for renal transplantation.
A randomized three-arm, parallel group, open label, prospective study was performed at 15 North American centers to compare three immunosuppressive regimens: tacrolimus + azathioprine (AZA) versus cyclosporine (Neoral) + mycophenolate mofetil (MMF) versus tacrolimus + MMF. All patients were first cadaveric kidney transplants receiving the same maintenance corticosteroid regimen. Only patients with delayed graft function (32%) received antilymphocyte induction. A total of 223 patients were randomized, transplanted, and followed for 1 year.
There were no significant differences in baseline demography between the three treatment groups. At 1 year the results are as follows: acute rejection 17% (95% confidence interval 9%, 26%) in tacrolimus + AZA; 20% (confidence interval 11%, 29%) in cyclosporine + MMF; and 15% (confidence interval 7%, 24%) in tacrolimus + MMF. The incidence of steroid resistant rejection requiring antilymphocyte therapy was 12% in the tacrolimus + AZA group, 11% in the cyclosporine + MMF group, and 4% in the tacrolimus + MMF group. There were no significant differences in overall patient or graft survival. Tacrolimus-treated patients had a lower incidence of hyperlipidemia through 6 months posttransplant. The incidence of posttransplant diabetes mellitus requiring insulin was 14% in the tacrolimus + AZA group, 7% in the cyclosporine + MMF and 7% in the tacrolimus + MMF groups.
All regimens yielded similar acute rejection rates and graft survival, but the tacrolimus + MMF regimen was associated with the lowest rate of steroid resistant rejection requiring antilymphocyte therapy.
Details
- Title: Subtitle
- Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mycophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation
- Creators
- Christopher Johnson - Medical College of Wisconsin, Milwaukee 53226, USANasimul AhsanThomas GonwaPhilip HalloranMark StegallMark HardyRobert MetzgerCharles Shield IIILeslie RocherJohn ScandlingJohn SorensenLaura MulloyJimmy LightClaudia CorwinGabriel DanovitchMichael WachsPaul Van VeldhuisenKim SalmDiane TolzmanWilliam E Fitzsimmons
- Resource Type
- Journal article
- Publication Details
- Transplantation, Vol.69(5), pp.834-841
- DOI
- 10.1097/00007890-200003150-00028
- PMID
- 10755536
- NLM abbreviation
- Transplantation
- ISSN
- 0041-1337
- eISSN
- 1534-6080
- Language
- English
- Date published
- 03/15/2000
- Academic Unit
- Pulmonary, Critical Care, and Occupational Medicine; Occupational and Environmental Health; Internal Medicine
- Record Identifier
- 9984094743002771
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