NCT00817687

Brief Summary

This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor. Patients will be randomized to one of two groups; the first group will have a biopsy at day 10, and the second group will receive standard management. All patients will be given CellCept as standard of care. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

Geographic Reach
1 country

17 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

First Submitted

Initial submission to the registry

December 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 9, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

December 16, 2008

Last Update Submit

July 5, 2012

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with >=25% increase in fibrosis score

    Day 0 to Week 52

Secondary Outcomes (3)

  • Renal function (creatinine clearance)

    From randomization to Week 52

  • Incidence and time of occurrence of clinical acute rejection

    From randomization to Week 52

  • Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes

    Throughout study

Study Arms (2)

1

EXPERIMENTAL
Drug: mycophenolate mofetil [CellCept]

2

NO INTERVENTION
Drug: mycophenolate mofetil [CellCept]

Interventions

mycophenolate mofetil [CellCept]DRUG

As prescribed; + early biopsy

1

Eligibility Criteria

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

You may qualify if:

  • adult patients, \>=18 years of age;
  • in receipt of an initial cadaveric kidney transplant;
  • in receipt of graft with biopsy;
  • in receipt of a 'marginal' kidney transplant.

You may not qualify if:

  • in receipt of a second kidney transplant;
  • in receipt of a multi-organ transplant or a double kidney transplant;
  • malignant tumor, or a history of cancer in past 5 years, other than successfully treated basal cell or spinocellular cancer or cancer in situ of cervix;
  • replicating hepatitis B and/or C, or HIV positive serology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Unknown Facility

Besançon, 25030, France

Location

Unknown Facility

Bordeaux, 33076, France

Location

Unknown Facility

Caen, 14033, France

Location

Unknown Facility

Clermont-Ferrand, 63000, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Limoges, 87042, France

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Nantes, 44035, France

Location

Unknown Facility

Paris, 75743, France

Location

Unknown Facility

Paris, 75908, France

Location

Unknown Facility

Poitiers, 86021, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Salouël, 80480, France

Location

Unknown Facility

Strasbourg, 67091, France

Location

Unknown Facility

Suresnes, 92151, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

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

December 16, 2008

First Posted

January 6, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 9, 2012

Record last verified: 2012-07

Locations

FR(17)