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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

NCT00533442 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2017-07-12

Study results available
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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.

Conditions

Interventions

DRUG

Rapamycin

Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

DRUG

Mycophenolate Mofetil

MMF 1 gm BID beginning 1st day postoperative day

DRUG

Tacrolimus

Part of standard maintenance.

DRUG

Steroids

Part of standard maintenance

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • George W Burke, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-09-30
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00533442 on ClinicalTrials.gov