NCT00275522

Brief Summary

The study is being done to compare the safety and effects (good and bad) of three different combinations of immunosuppression drugs used by kidney transplant recipients while also looking at their kidney function.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

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

December 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

January 20, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

January 10, 2006

Last Update Submit

January 19, 2010

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Calculated creatinine clearance at 12 months after transplantation.

Secondary Outcomes (5)

  • Calculated creatinine clearance at 26, 78, and 104 weeks post transplantation.

  • Serum creatinine at 26, 52, 78, and 104 weeks post transplantation.

  • Subject and graft survival at 26, 52, 78, and 104 weeks post transplantation.

  • Incidence and severity of biopsy-confirmed acute rejection at 26, 52, 78, and 108 weeks post transplantation.

  • Severity of rejection, including histological grade of the first acute rejection episode.

Interventions

SirolimusDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Participants must be at least between the ages of 18 and 75, and will be receiving their first or second kidney transplant.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Mark D. Stegall, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

December 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 20, 2010

Record last verified: 2010-01

Locations

US(1)