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

Roche

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: mycophenolate mofetil [CellCept]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00817687

ML21655

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.