NCT00133172

Brief Summary

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

14 active sites

Status
terminated

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

August 22, 2005

Last Update Submit

September 5, 2014

Conditions

Kidney Transplantation

Keywords

Treatment EfficacyTreatment EffectivenessAnti-rejection therapyImmunosuppressionAntirejectionRenal TransplantationTransplantation, RenalTransplantation, KidneyGrafting, Kidney

Outcome Measures

Primary Outcomes (1)

  • Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)

    3 months post transplant

Secondary Outcomes (2)

  • Biopsy proven chronic allograft nephropathy(CAN)

    2 years post transplant

  • Patient and graft survival rates

    End of study (5 years)

Study Arms (2)

1

EXPERIMENTAL

Steroid rapid 5-day withdrawal

Drug: TacrolimusDrug: mycophenolate mofetilDrug: Prednisone

2

ACTIVE COMPARATOR

Standard steroid maintenance

Drug: TacrolimusDrug: mycophenolate mofetilDrug: Prednisone

Interventions

TacrolimusDRUG

IV

Also known as: Prograf, FK506
12
mycophenolate mofetilDRUG

IV

Also known as: Cellcept
12
PrednisoneDRUG

IV

12

Eligibility Criteria

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

You may qualify if:

  • Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
  • Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
  • Subject is 18 years of age or over at the time of 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 60 years of age or older
  • Recipients of donation after cardiac death (DCD) donors
  • Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
  • Subjects with a second renal allograft who had their original graft for \< 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
  • Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) \>20
  • Subjects with hepatitis B \& C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
  • Subjects receiving an allograft with cold ischemia time 24 hours or greater
  • Subjects who have received an investigational drug within three months prior to randomization
  • Subjects who are breastfeeding
  • Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
  • Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Calgary, Alberta, T2N 2T9, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 2B7, Canada

Location

Unknown Facility

Vancouver, British Columbia, V5Z 1C6, Canada

Location

Unknown Facility

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 4A6, Canada

Location

Unknown Facility

London, Ontario, N6A 5A5, Canada

Location

Unknown Facility

Ottawa, Ontario, K1H 7W9, Canada

Location

Unknown Facility

Toronto, Ontario, M5C2T2, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2N2, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4M1, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Unknown Facility

Québec, Quebec, G1R 2J6, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

MeSH Terms

Interventions

TacrolimusMycophenolic AcidPrednisone

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Astellas Pharma Canada, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 23, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

CA(14)