Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/4/2016 |
| Start Date: | September 2000 |
| End Date: | May 2016 |
Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
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.
mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal
failure, who presented for a kidney-pancreas transplant.
This is a randomized, prospective single center study evaluating the two drugs above.
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).
We found this trial at
1
site
1601 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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