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Completed

NCT Number: NCT00533442

Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

About this study

This is a randomized, prospective single center study evaluating the two maintenance drugs above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with Type 1 diabetes and end stage renal disease.
  • Women of childbearing potential must have had a negative pregnancy test (serum or urine).
  • Patient agrees to participate in the study and sign an informed consent.
  • Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
  • Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

Exclusion criteria

  • Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
  • Patient is currently abusing drugs or alcohol.
  • Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).

Treatment and study plan

Rapamycin

Drug

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)

Mycophenolate mofetil

Drug

MMF 1 gm BID beginning 1st day postoperative day

Other names: Cellcept, MMF

Tacrolimus

Drug

Part of standard maintenance.

Other names: TAC

Steroids

Drug

Part of standard maintenance

Other names: Corticosteroids

Primary outcomes

  1. Event-Specific Survival Comparisons

    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.

Secondary outcomes

  1. Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.

    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.

  2. Overall Pancreas Transplant Function 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

Important dates

Study start
2000
Primary completion
2016
Study completion
2016
First posted
Sep 21, 2007
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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