NCT00510913

Brief Summary

A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 1999

Geographic Reach
1 country

18 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

February 1, 1999

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
Last Updated

August 2, 2007

Status Verified

July 1, 2007

First QC Date

July 31, 2007

Last Update Submit

July 31, 2007

Conditions

Graft RejectionKidney Transplantation

Keywords

Treatment efficacyTransplantation rejectionKidney transplantationCyclosporinetacrolimus

Outcome Measures

Primary Outcomes (1)

  • Graft Survival

    5 years

Secondary Outcomes (1)

  • Patient survival, Graft Loss

    5 years

Interventions

tacrolimusDRUG
Also known as: Prograf®, FK506

Eligibility Criteria

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

You may qualify if:

  • Patient has been on cyclosporine-based immunosuppression regimen since the transplant
  • Patient has at least one pre-defined risk factor for chronic allograft failure

You may not qualify if:

  • Patient is dialysis dependent
  • Patient is recipient of a solid organ transplant other than the kidney

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

New Haven, Connecticut, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • John Holman, MD

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 2, 2007

Study Start

February 1, 1999

Study Completion

September 1, 2000

Last Updated

August 2, 2007

Record last verified: 2007-07

Locations

US(18)