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Completed

NCT Number: NCT00817687

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mycophenolate mofetil [CellCept]

Drug

As prescribed; + early biopsy

Primary outcomes

  1. Proportion of patients with >=25% increase in fibrosis score

    Time frame: Day 0 to Week 52

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 6, 2009
Registry last updated
Jul 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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