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A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00817687
First received: December 16, 2008
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
 Drug: mycophenolate mofetil [CellCept]
 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 Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with >=25% increase in fibrosis score [ Time Frame: Day 0 to Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function (creatinine clearance) [ Time Frame: From randomization to Week 52 ] [ Designated as safety issue: No ]
  • Incidence and time of occurrence of clinical acute rejection [ Time Frame: From randomization to Week 52 ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
As prescribed; + early biopsy
No Intervention: 2 Drug: mycophenolate mofetil [CellCept]
As prescribed; + standard treatment

  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;
  • in receipt of an initial cadaveric kidney transplant;
  • in receipt of graft with biopsy;
  • in receipt of a 'marginal' kidney transplant.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817687

Locations
France
Besancon, France, 25030
Bordeaux, France, 33076
Caen, France, 14033
Clermont-ferrand, France, 63000
Lille, France, 59037
Limoges, France, 87042
Marseille, France, 13385
Nantes, France, 44035
Paris, France, 75908
Paris, France, 75743
Poitiers, France, 86021
Rouen, France, 76031
Salouel, France, 80480
Strasbourg, France, 67091
Suresnes, France, 92151
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54511
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: NCT00817687     History of Changes
Other Study ID Numbers: ML21655
Study First Received: December 16, 2008
Last Updated: July 5, 2012
Health Authority: France:AFSSAPS

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

ClinicalTrials.gov processed this record on May 21, 2013