Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: Astellas Pharma Inc
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Pancreatin; Pancrelipase; Sirolimus; Tacrolimus

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).