NCT00717314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2008

Typical duration for phase_4

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 29, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

3.2 years

First QC Date

July 16, 2008

Results QC Date

June 4, 2014

Last Update Submit

September 23, 2014

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Percentage of Participants With Graft Loss or Death at Week 52

    Week 52

  • Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52

    Week 52

  • Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])

    Baseline and Weeks 16, 28, and 40

  • Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52

    Week 52

  • Percentage Change in Creatinine Clearance From Baseline

    Weeks 16, 28, 40, and 52

  • +1 more secondary outcomes

Study Arms (2)

MMF, 50% CNI Reduction

EXPERIMENTAL

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 mofetilDrug: CNI (50%)

MMF, ≥75% CNI Reduction

EXPERIMENTAL

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 mofetilDrug: CNI (≥75%)

Interventions

Mycophenolate mofetilDRUG

1.5 to 2.0 g daily PO BID

Also known as: CellCept
MMF, 50% CNI ReductionMMF, ≥75% CNI Reduction
CNI (50%)DRUG

50% reduction from BL

MMF, 50% CNI Reduction
CNI (≥75%)DRUG

≥75% reduction from BL

MMF, ≥75% CNI Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Beijing, 100039, China

Location

Unknown Facility

Beijing, 100054, China

Location

Unknown Facility

Changsha, 410013, China

Location

Unknown Facility

Chengdu, 610041, China

Location

Unknown Facility

Chongqing, 400038, China

Location

Unknown Facility

Guangzhou, 510080, China

Location

Unknown Facility

Jiangsu, 210029, China

Location

Unknown Facility

Shanghai, 200003, China

Location

Unknown Facility

Shanghai, 200080, China

Location

Unknown Facility

Tianjin, 300192, China

Location

Unknown Facility

Xi'an, 710032, China

Location

MeSH Terms

Interventions

Mycophenolic Acidcni protein, Drosophila

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

May 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 29, 2014

Results First Posted

September 29, 2014

Record last verified: 2014-09

Locations

CN(11)