Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
George W. Burke, University of Miami
ClinicalTrials.gov Identifier:
NCT00533442
First received: September 19, 2007
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 190
Study Start Date: September 2000
Estimated Study Completion Date: October 2013
Primary Completion Date: August 2010 (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:

10-15ng/ml)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533442

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT00533442     History of Changes
Other Study ID Numbers: UM-IRB # 2000-176
Study First Received: September 19, 2007
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
Rapamycin
Mycophenolate mofetil
kidney-pancreas transplant

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Sirolimus
Everolimus
Tacrolimus
Mycophenolic Acid
Pancreatin
Pancrelipase
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 22, 2014