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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817687

Enrollment

Registered

2009-01-06

Start date

2009-01-31

Completion date

2012-01-31

Last updated

2012-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

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.

Interventions

DRUGmycophenolate mofetil [CellCept]

As prescribed; + early biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Proportion of patients with >=25% increase in fibrosis score	Day 0 to Week 52

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026