CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 23 enrolled
Drug / intervention
MMF +2 moredrug
Likely dose
MMF 1 gfrom 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/NCT01033864
NCT01033864Phase 4Completed
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Comparison of Pharmocokinetics of Mycophenolate Mofetil and Enteric Coated Mycophenolate Sodium in Calcineurininhibitor-free Treated Patients After Renal Transplantation

Hoffmann-La Roche·interventional·Posted Dec 17, 2009·Updated Aug 27, 2015

In Brief

A Phase 4 clinical trial evaluating MMF, EC-MPS, and 1 other intervention for Kidney Transplantation. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2009
Enrollment StartNov 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.5 years ago

Interventions

MMFdrug

1 g per day b.i.d. p.o. for at least 1 month

EC-MPSdrug

720 mg b.i.d. p.o. for at least 1 month

Prednisonedrug

5 mg per day p.o.