NCT00637143

Brief Summary

The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
107

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 1999

Longer than P75 for phase_4

Geographic Reach
1 country

13 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

April 1, 1999

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

March 10, 2008

Last Update Submit

February 15, 2017

Conditions

Renal TransplantationChronic Renal Allograft Failure

Keywords

Renal transplantCyclosporineTacrolimusInterventionInterstitial Fibrosis Tubular AtrophyChronic Renal Allograft Failure

Outcome Measures

Primary Outcomes (1)

  • Graft Survival

    5 years

Secondary Outcomes (1)

  • Patient Survival

    5 years

Study Arms (2)

1

EXPERIMENTAL

Oral

Drug: Tacrolimus

2

ACTIVE COMPARATOR

Oral

Drug: Cyclosporine

Interventions

TacrolimusDRUG

Oral

Also known as: FK506, Prograf
1
CyclosporineDRUG

Oral

Also known as: Neoral
2

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
  • Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
  • Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
  • Serum creatinine: Male: \>=2.0mg/dL (176.8 umol/L); Female: \>= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
  • Serum creatinine \> 30% increased over post-discharge nadir
  • Patient has had a renal biopsy \> 3 months after transplant and within 6 months prior to enrollment
  • Patient or legal guardian has signed and dated an IRB approved informed consent document
  • Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)

You may not qualify if:

  • Patient is dialysis dependent and has recurrence of primary or de novo renal disease
  • Patient has an estimated creatinine clearance \<25mL/min
  • Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
  • Baseline biopsy shows acute rejection Grade \>=IIB using Banff 95 criteria or \>= Grade IIA using Banff 97 criteria
  • Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
  • Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
  • Patient is a known carrier of any of the HIV viruses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

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

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Unknown Facility

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 4A6, Canada

Location

Unknown Facility

London, Ontario, N6A 5A5, Canada

Location

Unknown Facility

Toronto, Ontario, M5C 2T2, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2N2, Canada

Location

Unknown Facility

Montreal, Quebec, H1T 2M4, Canada

Location

Unknown Facility

Montreal, Quebec, H3A 1A1, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Related Publications (1)

  • Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B. Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.

    PMID: 18852662BACKGROUND

Related Links

MeSH Terms

Interventions

TacrolimusCyclosporine

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Central Contact

    Astellas Pharma Canada, Inc.

    STUDY CHAIR

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

March 10, 2008

First Posted

March 17, 2008

Study Start

April 1, 1999

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

February 16, 2017

Record last verified: 2017-02

Locations

CA(13)