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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717314
First received: July 16, 2008
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Drug: Mycophenolate mofetil
Drug: CNI (50%)
Drug: CNI (≥75%)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20% [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With Graft Loss or Death at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Graft loss was defined for this protocol as re-transplantion or death.

  • Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    BPAR was graded according to Banff criteria.

  • Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min]) [ Time Frame: Baseline and Weeks 16, 28, and 40 ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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).

  • Percentage Change in Creatinine Clearance From Baseline [ Time Frame: Weeks 16, 28, 40, and 52 ] [ Designated as safety issue: No ]
    Creatinine clearance was calculated using the Cockcroft and Gault formula.

  • Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    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.


Enrollment: 87
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMF, 50% CNI Reduction
Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52.
Drug: Mycophenolate mofetil
1.5 to 2.0 g daily PO BID
Other Name: CellCept
Drug: CNI (50%)
50% reduction from BL
Experimental: MMF, ≥75% CNI Reduction
Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52.
Drug: Mycophenolate mofetil
1.5 to 2.0 g daily PO BID
Other Name: CellCept
Drug: CNI (≥75%)
≥75% reduction from BL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00717314

Locations
China
Beijing, China, 100054
Beijing, China, 100039
Changsha, China, 410013
Chengdu, China, 610041
Chongqing, China, 400038
Guangzhou, China, 510080
Jiangsu, China, 210029
Shanghai, China, 200080
Shanghai, China, 200003
Tianjin, China, 300192
Xi'an, China, 710032
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717314     History of Changes
Other Study ID Numbers: ML21241
Study First Received: July 16, 2008
Results First Received: June 4, 2014
Last Updated: September 23, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014