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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00817687
Recruitment Status : Completed
First Posted : January 6, 2009
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: mycophenolate mofetil [CellCept] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
As prescribed; + early biopsy
No Intervention: 2 Drug: mycophenolate mofetil [CellCept]
As prescribed; + standard treatment

Primary Outcome Measures :
  1. Proportion of patients with >=25% increase in fibrosis score [ Time Frame: Day 0 to Week 52 ]

Secondary Outcome Measures :
  1. Renal function (creatinine clearance) [ Time Frame: From randomization to Week 52 ]
  2. Incidence and time of occurrence of clinical acute rejection [ Time Frame: From randomization to Week 52 ]
  3. Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes [ Time Frame: Throughout study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00817687

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, 75743
Paris, France, 75908
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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00817687     History of Changes
Other Study ID Numbers: ML21655
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action