Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tacrolimus; Drug: MMF; Drug: Corticosteroids (Prednisone)

• Registration Number: NCT00885820
• Lead Sponsor: Astellas Pharma Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2004-07
• Study Completion: 2006-01
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	MMF	No protocol biopsies
2	Corticosteroids (Prednisone)	No protocol biopsies
1	MMF	Protocol biopsies at 1, 2 and 3 months
1	Corticosteroids (Prednisone)	Protocol biopsies at 1, 2 and 3 months
1	Tacrolimus	Protocol biopsies at 1, 2 and 3 months
2	Tacrolimus	No protocol biopsies

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The incidence of subclinical rejection at 6 months	6 months
Prevalence of chronic renal histopathology at 24 months	24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion	6, 12 and 24 moths