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OpenTrials
Completed

NCT Number: NCT00885820

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

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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

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
  • If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion criteria

  • Recipients of a kidney from a donor over 65 years of age
  • Recipient of non-related donor kidney with peak pre-transplant PRA > 50
  • Subject has lost a previous graft to rejection less than one year from transplant
  • Subject who has received an investigational drug within three months prior to randomization
  • Subjects who are pregnant or breastfeeding
  • Subject receives a kidney lacking a pre-implantation biopsy
  • Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol

Treatment and study plan

Tacrolimus

Drug

Oral

Other names: Prograf, FK506

MMF

Drug

Oral

Other names: Cellcept

Corticosteroids (Prednisone)

Drug

Oral

Other names: Methylprednisolone, Prednisone

Primary outcomes

  1. The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months

    Time frame: 6 months

Secondary outcomes

  1. The incidence of subclinical rejection at 6 months

    Time frame: 6 months

  2. Prevalence of chronic renal histopathology at 24 months

    Time frame: 24 months

  3. Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion

    Time frame: 6, 12 and 24 moths

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Official study title

The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

Important dates

Study start
2001
Primary completion
2004
Study completion
2006
First posted
Apr 22, 2009
Registry last updated
Sep 18, 2014

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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