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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817687
• Other study ID #: ML21655
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2008
• Last updated: July 5, 2012
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: July 2012
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France:AFSSAPS
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• mycophenolate mofetil [CellCept]
As prescribed; + early biopsy
• mycophenolate mofetil [CellCept]
As prescribed; + standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with >=25% increase in fibrosis score		Day 0 to Week 52	No
Secondary	Renal function (creatinine clearance)		From randomization to Week 52	No
Secondary	Incidence and time of occurrence of clinical acute rejection		From randomization to Week 52	No
Secondary	Adverse events, laboratory parameters, cancers and lymphoproliferative syndromes		Throughout study	No