A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717314
• Other study ID #: ML21241
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2008
• Last updated: September 23, 2014
• Start date: May 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Mycophenolate mofetil
1.5 to 2.0 g daily PO BID
• CNI (50%)
50% reduction from BL
• CNI (=75%)
=75% reduction from BL

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%	The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.	Week 52	No
Secondary	Percentage of Participants With Graft Loss or Death at Week 52	Graft loss was defined for this protocol as re-transplantion or death.	Week 52	No
Secondary	Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52	BPAR was graded according to Banff criteria.	Week 52	No
Secondary	Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])	Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) [(140 minus (-) age in years) multiplied by (*) (weight in kilograms (kg)] divided by [72 * serum creatinine in milligrams per deciliter (mg/dL)]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).	Baseline and Weeks 16, 28, and 40	No
Secondary	Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52	Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = [(140 - age in years) * (weight in kg] divided by [72 * serum creatinine in mg/dL]. For adult females, creatinine clearance in mL/min = 0.85 * [(140 - age in years) * (weight in kg)] divided by (72 * serum creatinine in mg/dL).	Week 52	No
Secondary	Percentage Change in Creatinine Clearance From Baseline	Creatinine clearance was calculated using the Cockcroft and Gault formula.	Weeks 16, 28, 40, and 52	No
Secondary	Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of =20% at Week 52	The percentage of participants who experienced at least 1 of the following: a =20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.	Week 52	No