CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 170 enrolled
Drug / intervention
Rapamycin +3 moredrug
Likely dose
Rapamycin 4mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00533442
NCT00533442Phase 2Completed
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Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone

University of Miami·interventional·Posted Sep 21, 2007·Updated Jul 12, 2017

In Brief

A Phase 2 clinical trial evaluating Rapamycin, Mycophenolate Mofetil, and 2 other interventions for Type 1 Diabetes. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2007
Enrollment StartSep 1, 2000
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 15.7 yearsPosted 18.8 years ago

Interventions

Rapamycindrug

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.

Mycophenolate Mofetildrug

MMF 1 gm BID beginning 1st day postoperative day

Tacrolimusdrug

Part of standard maintenance.

Steroidsdrug

Part of standard maintenance