CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 68 enrolled
Drug / intervention
mycophenolate mofetildrug
Likely dose
mycophenolate mofetil 1.5 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/NCT01014442
NCT01014442Phase 3Completed
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Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients

Hoffmann-La Roche·interventional·Posted Nov 17, 2009·Updated Feb 10, 2017

In Brief

A Phase 3 clinical trial evaluating mycophenolate mofetil for Lung Transplantation. Completed, enrolled 68 participants across 1 site.

Detailed Summary

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease \[COPD\], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency \[A1AD\]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Study Details

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

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.6 years ago

Interventions

mycophenolate mofetildrug

1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation