Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

Completed · Phase 2

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00533442

Run by

University of Miami

People needed

170

Starts

2000-09-01

Expected to finish

2016-05-01

Last updated by the study team

2017-07-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Miami, Miller School of Medicine — Miami, Florida, United States

Full record on ClinicalTrials.gov

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