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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533442
First Posted: September 21, 2007
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
George W. Burke, University of Miami
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes Drug: Rapamycin Drug: Mycophenolate Mofetil Drug: Tacrolimus Drug: Steroids Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 170
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: Tacrolimus plus MMF plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Drug: Mycophenolate Mofetil
MMF 1 gm BID beginning 1st day postoperative day
Other Names:
  • Cellcept
  • MMF
Drug: Tacrolimus
Part of standard maintenance.
Other Name: TAC
Drug: Steroids
Part of standard maintenance
Other Name: Corticosteroids
Experimental: Tacrolimus plus Rapamycin plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
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: Tacrolimus
Part of standard maintenance.
Other Name: TAC
Drug: Steroids
Part of standard maintenance
Other Name: Corticosteroids

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: George W. Burke, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT00533442     History of Changes
Other Study ID Numbers: 20000176
First Submitted: September 19, 2007
First Posted: September 21, 2007
Results First Submitted: March 6, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017

Keywords provided by George W. Burke, University of Miami:
Rapamycin
Mycophenolate Mofetil (MMF)
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
Tacrolimus
Sirolimus
Everolimus
Antilymphocyte Serum
Thymoglobulin
Mycophenolic Acid
Pancrelipase
Pancreatin
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
Antibiotics, Antitubercular
Antitubercular Agents
Gastrointestinal Agents