Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885820
• Other study ID #: FKC-008
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2009
• Last updated: September 17, 2014
• Start date: September 2001
• Est. completion date: January 2006

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2006
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
Oral
• MMF
Oral
• Corticosteroids (Prednisone)
Oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Canada, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The incidence of subclinical rejection at 6 months		6 months	No
Secondary	Prevalence of chronic renal histopathology at 24 months		24 months	No
Secondary	Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion		6, 12 and 24 moths	No

External Links

•   Link to Results on JAPIC - enter 140606 in the JapicCTI-RNo. field