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Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885820
First Posted: April 22, 2009
Last Update Posted: September 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
April 20, 2009
April 22, 2009
September 18, 2014
September 2001
July 2004   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00885820 on ClinicalTrials.gov Archive Site
  • The incidence of subclinical rejection at 6 months [ Time Frame: 6 months ]
  • Prevalence of chronic renal histopathology at 24 months [ Time Frame: 24 months ]
  • Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion [ Time Frame: 6, 12 and 24 moths ]
Same as current
Not Provided
Not Provided
 
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
  • Drug: Tacrolimus
    Oral
    Other Names:
    • Prograf
    • FK506
  • Drug: MMF
    Oral
    Other Name: Cellcept
  • Drug: Corticosteroids (Prednisone)
    Oral
    Other Names:
    • Methylprednisolone
    • Prednisone
  • Experimental: 1
    Protocol biopsies at 1, 2 and 3 months
    Interventions:
    • Drug: Tacrolimus
    • Drug: MMF
    • Drug: Corticosteroids (Prednisone)
  • Active Comparator: 2
    No protocol biopsies
    Interventions:
    • Drug: Tacrolimus
    • Drug: MMF
    • Drug: Corticosteroids (Prednisone)
Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
January 2006
July 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00885820
FKC-008
Yes
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Study Director: Use Central Contact Astellas Pharma Canada, Inc.
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP