NCT00297765

Brief Summary

A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
323

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Typical duration for phase_4

Geographic Reach
1 country

42 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

January 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 26, 2008

Status Verified

December 1, 2007

First QC Date

February 28, 2006

Last Update Submit

August 25, 2008

Conditions

Renal Transplantation

Keywords

Renal TransplantationTherapeuticsTreatment OutcomeSafety

Outcome Measures

Primary Outcomes (1)

  • The effect of conversion from cyclosporine to Prograf-based therapy on renal function

    12 months

Secondary Outcomes (1)

  • Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival

    24 months

Interventions

Tacrolimus, Prograf®DRUG

Eligibility Criteria

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

You may qualify if:

  • Patient was 18 years of age at the time of transplant.
  • Patient is at least 6 months post-transplant.

You may not qualify if:

  • Patient is the recipient of a solid organ transplant other than the kidney.
  • Patient is a known carrier of any of the HIV viruses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (42)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Little Rock, Arkansas, 72205, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Denver, Colorado, 80262, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20037, United States

Location

Unknown Facility

Atlanta, Georgia, 30309, United States

Location

Unknown Facility

Augusta, Georgia, 30912, United States

Location

Unknown Facility

Honolulu, Hawaii, 96817, United States

Location

Unknown Facility

Peoria, Illinois, 61603, United States

Location

Unknown Facility

Indianapolis, Indiana, 46202, United States

Location

Unknown Facility

Shreveport, Louisiana, 71103, United States

Location

Unknown Facility

Portland, Maine, 04102, United States

Location

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

Unknown Facility

Ann Arbor, Michigan, 48109, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Omaha, Nebraska, 68198, United States

Location

Unknown Facility

Livingston, New Jersey, 07039, United States

Location

Unknown Facility

West Orange, New Jersey, 07052, United States

Location

Unknown Facility

Buffalo, New York, 14203, United States

Location

Unknown Facility

Long Island City, New York, 11794, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Greenville, North Carolina, 27834, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19102, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19104, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19141, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Nashville, Tennessee, 37232, United States

Location

Unknown Facility

Dallas, Texas, 75204, United States

Location

Unknown Facility

Galveston, Texas, 77555, United States

Location

Unknown Facility

San Antonio, Texas, 78284, United States

Location

Unknown Facility

Salt Lake City, Utah, 84132, United States

Location

Unknown Facility

Richmond, Virginia, 23298, United States

Location

Unknown Facility

Seattle, Washington, 98104, United States

Location

Unknown Facility

Spokane, Washington, 99208, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • John Holman, MD

    Astellas Pharma US, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 1, 2006

Study Start

January 1, 2003

Study Completion

March 1, 2006

Last Updated

August 26, 2008

Record last verified: 2007-12

Locations

US(42)