CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 668 enrolled
Drug / intervention
Tacrolimus Modified Release (MR) +3 moredrug
Likely dose
Tacrolimus (immediate-release or modified-release) trough 7-16 ng/mL days 0-90 then 5-15 ng/mL thereafter; Cyclosporine trough 125-400 ng/mL days 0-90 then 100-300 ng/mL thereafter; Mycophenolate mofetil oralAI-extracted
Key inclusion· 2
  • ✓Primary or retransplanted non-HLA-identical living or cadaveric kidney transplant recipient
  • ✓Age ≥12 years
Key exclusion· 8
  • ✕Recipient or donor is HIV seropositive
  • ✕Current malignancy or history of malignancy
  • ✕Significant liver disease
  • ✕Uncontrolled concomitant infection or unstable medical condition

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

Search/NCT00064701
NCT00064701Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf (Tacrolimus)/MMF, Modified Release (MR) Tacrolimus/MMF and Neoral (Cyclosporine)/MMF in de Novo Kidney Transplant Recipients

Astellas Pharma Inc·interventional·Posted Jul 14, 2003·Updated Dec 5, 2013

In Brief

A Phase 3 clinical trial evaluating Tacrolimus Modified Release (MR), Tacrolimus, and 2 other interventions for Kidney Transplantation. Completed, enrolled 668 participants across 57 sites in 3 countries.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesBrazil, Canada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 14, 2003
Enrollment StartJun 1, 2003
Primary CompletionMar 1, 2005
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 23.0 years ago

Interventions

Tacrolimus Modified Release (MR)drug

The target range for whole blood tacrolimus trough concentrations was 7 to 16 ng/mL for days 0 through 90, and 5 to 15 ng/mL thereafter.

Tacrolimusdrug

The target range for whole blood tacrolimus trough concentrations was the recommended trough concentration range for Prograf: 7 to 16 ng/mL for days 0 through 90 and 5 to 15 ng/mL thereafter.

cyclosporine microemulsiondrug

The target range for whole blood cyclosporine trough concentrations was 125 to 400 ng/mL for days 0 through 90, and 100 to 300 ng/mL thereafter.

mycophenolate mofetildrug

Oral