Phase 2
N=170
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00533442 ↗Enrolled (actual)
170
Serious AEs
45.9%
Results posted
Jul 2017
Primary outcome: Primary: Event-Specific Survival Comparisons — 22; 8; 9; 1 Participants — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rapamycin (Drug); Mycophenolate Mofetil (Drug); Tacrolimus (Drug); Steroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-Specific Survival Comparisons |
22; 8; 9; 1; 18; 10 | 0.01 sig |
| SECONDARY Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant. |
71.2; 67.2; 63.0; 61.5; 56.5; 61.9 | 0.21 |
| SECONDARY Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant. |
1.15; 1.08; 0.990; 0.986; 1.17; 1.22 | .47 |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT00533442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.