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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
George W. Burke, University of Miami Identifier:
First received: September 19, 2007
Last updated: June 2, 2016
Last verified: June 2016
This study was designed to determine which 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.

Condition Intervention Phase
Type 1 Diabetes Drug: Rapamycin Drug: Tacrolimus and mycophenolate mofetil Drug: Rapamune and Tacrolimus Drug: Mycophenolate Mofetil Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

Resource links provided by NLM:

Further study details as provided by George W. Burke, University of Miami:

Primary Outcome Measures:
  • Freedom from acute rejection; kidney or pancreas transplant loss, and death at one year after transplant. [ Time Frame: one to seven years ]

Secondary Outcome Measures:
  • 12 month safety and efficacy assessments including side effects and overall kidney and pancreas transplant function. [ Time Frame: one to seven years ]

Enrollment: 190
Study Start Date: September 2000
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TAC and MMF and Steroid
This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.
Drug: Tacrolimus and mycophenolate mofetil
MMF 1 gm BID beginning 1st day postoperative day
Other Names:
  • Prograf
  • Cellcept
Active Comparator: tacrolimus and rapamune
Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.
Drug: Rapamycin
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 Name: Rapamune® (sirolimus)
Drug: Rapamune and Tacrolimus

Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:


Other Name: Rapamune
Drug: Mycophenolate Mofetil
Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Detailed Description:
This is a randomized, prospective single center study evaluating the two drugs above.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its identifier: NCT00533442

United States, Florida
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Astellas Pharma Inc
Principal Investigator: George W Burke, MD University of Miami
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: George W. Burke, Professor of Surgery, University of Miami Identifier: NCT00533442     History of Changes
Other Study ID Numbers: 20000176
Study First Received: September 19, 2007
Last Updated: June 2, 2016

Keywords provided by George W. Burke, University of Miami:
Mycophenolate mofetil
kidney-pancreas transplant

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Gastrointestinal Agents processed this record on June 26, 2017