Clincosm LogoSign in Get a demo

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00885820
Collaborator
Astellas Pharma Canada, Inc. (Industry)
240
Enrollment
12
Locations
2
Arms
52
Duration (Months)
20
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
Study Start Date :
Sep 1, 2001
Actual Primary Completion Date :
Jul 1, 2004
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Protocol biopsies at 1, 2 and 3 months

Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506

    • Drug: MMF
    Oral
    Other Names:
  • Cellcept

    • Drug: Corticosteroids (Prednisone)
    Oral
    Other Names:
  • Methylprednisolone
  • Prednisone

    		•
    Active Comparator: 2

    No protocol biopsies

    Drug: Tacrolimus
    Oral
    Other Names:
  • Prograf
  • FK506

    • Drug: MMF
    Oral
    Other Names:
  • Cellcept

    • Drug: Corticosteroids (Prednisone)
    Oral
    Other Names:
  • Methylprednisolone
  • Prednisone

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [6 months]

    Secondary Outcome Measures

    1. The incidence of subclinical rejection at 6 months [6 months]

    2. Prevalence of chronic renal histopathology at 24 months [24 months]

    3. Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion [6, 12 and 24 moths]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palo Alto California United States 94304-1510
    2 Calgary Alberta Canada T2N 2T9
    3 Edmonton Alberta Canada T6G 2B7
    4 Vancouver British Columbia Canada V5Z 1M9
    5 Vancouver British Columbia Canada V6Z 1Y6
    6 Winnipeg Manitoba Canada R3A 1R9
    7 Hamilton Ontario Canada L8N 4A6
    8 Ottawa Ontario Canada K1H 7W9
    9 Montreal Quebec Canada H1T 2M4
    10 Montreal Quebec Canada H2L 4M1
    11 Quebec City Quebec Canada G1R 2J6
    12 Saskatoon Saskatchewan Canada S7M 0Z9

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma Canada, Inc.

    Investigators

    • Study Director: Use Central Contact, Astellas Pharma Canada, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Astellas Pharma Inc
    ClinicalTrials.gov Identifier:
    NCT00885820
    Other Study ID Numbers:
    • FKC-008
    First Posted:
    Apr 22, 2009
    Last Update Posted:
    Sep 18, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Astellas Pharma Inc
    Kidney Transplantation
    Tacrolimus
    Immunosuppression
    Graft Survival
    Additional relevant MeSH terms:
    Prednisone
    Methylprednisolone
    Tacrolimus

    Study Results

    No Results Posted as of Sep 18, 2014