Rapamycin vs Mycophenolate Mofetil in Kidney-Pancreas Recipients
Information source: University of Miami
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Rapamycin vs Mycophenolate Mofetil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Miami Official(s) and/or principal investigator(s):
George W Burke, MD, Principal Investigator, Affiliation: University of Miami,Miller School of Medicine
Overall contact:
George W Burke, MD, Phone: 305-355-5111, Email: gburke@med.miami.edu
Summary
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.
Clinical Details
Official title: Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
Study design: Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Freedom from acute rejection;kidney or pancreas transplant loss, and death at one year after transplant.
Secondary outcome: 12 month safety and efficacy assessments including side effects and overall kidney and pancreas transplant function.
Detailed description:
This is a randomized, prospective single center study evaluating the two drugs above.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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).
Locations and Contacts
George W Burke, MD, Phone: 305-355-5111, Email: gburke@med.miami.edu
University of Miami, Miller School of Medicine, Miami, Florida 33136, United States; Recruiting
George W Burke, MD, Principal Investigator
Additional Information
Starting date: September 2000
Ending date: August 2012
Last updated: September 19, 2007
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