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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885820
Enrollment
240
Registered
2009-04-22
Start date
2001-09-30
Completion date
2006-01-31
Last updated
2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation, Tacrolimus, Immunosuppression, Graft Survival

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.

Interventions

DRUGTacrolimus

Oral

DRUGMMF

Oral

DRUGCorticosteroids (Prednisone)

Oral

Sponsors

Astellas Pharma Canada, Inc.
CollaboratorINDUSTRY
Astellas Pharma Inc
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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 months6 months

Secondary

MeasureTime frame
The incidence of subclinical rejection at 6 months6 months
Prevalence of chronic renal histopathology at 24 months24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion6, 12 and 24 moths

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026