Clinical trial NCT00717314: A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Official title: A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + \>=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* single organ recipients of liver allograft;
* CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;
* \>=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);
* negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.

Exclusion Criteria:

* treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;
* known contraindications to CNI, corticosteroids or CellCept.

Primary outcomes:
measure: Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants With Graft Loss or Death at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52
timeFrame: Week 52
measure: Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])
timeFrame: Baseline and Weeks 16, 28, and 40
measure: Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52
timeFrame: Week 52
measure: Percentage Change in Creatinine Clearance From Baseline
timeFrame: Weeks 16, 28, 40, and 52
measure: Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Guangzhou
country: China
city: Jiangsu
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Tianjin
country: China
city: Xi'an
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: