University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
NCT Number: NCT00533442
This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Miami, Florida, 33136, United States
This is a randomized, prospective single center study evaluating the two maintenance drugs above.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.
Other names: Rapamune® (sirolimus)
MMF 1 gm BID beginning 1st day postoperative day
Other names: Cellcept, MMF
Part of standard maintenance.
Other names: TAC
Part of standard maintenance
Other names: Corticosteroids
Time frame: over 1-10 years post-transplant
Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.
Time frame: at 1-5 years post-transplant
Comparisons of renal function (eGFR, measured in mL/min/1.73 m^2) at 12, 36, and 60 months post-transplant.
Time frame: at 1-5 years post-transplant
Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.
University of Miami
Other
Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
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