NCT00885820

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2001

Longer than P75 for phase_4

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

April 20, 2009

Last Update Submit

September 17, 2014

Conditions

Kidney Transplantation

Keywords

Kidney TransplantationTacrolimusImmunosuppressionGraft Survival

Outcome Measures

Primary Outcomes (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 Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Protocol biopsies at 1, 2 and 3 months

Drug: TacrolimusDrug: MMFDrug: Corticosteroids (Prednisone)

2

ACTIVE COMPARATOR

No protocol biopsies

Drug: TacrolimusDrug: MMFDrug: Corticosteroids (Prednisone)

Interventions

TacrolimusDRUG

Oral

Also known as: Prograf, FK506
12
MMFDRUG

Oral

Also known as: Cellcept
12
Corticosteroids (Prednisone)DRUG

Oral

Also known as: Methylprednisolone, Prednisone
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Palo Alto, California, 94304-1510, United States

Location

Unknown Facility

Calgary, Alberta, T2N 2T9, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 2B7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Unknown Facility

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 4A6, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 7W9, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4M1, Canada

Location

Unknown Facility

Québec, Quebec, G1R 2J6, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Related 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.

    PMID: 19935461BACKGROUND

MeSH Terms

Interventions

TacrolimusMycophenolic AcidAdrenal Cortex HormonesPrednisoneMethylprednisolone

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPrednisolonePregnadienetriols

Study Officials

  • Use Central Contact

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

September 1, 2001

Primary Completion

July 1, 2004

Study Completion

January 1, 2006

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

US(1)CA(11)