Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal

PHASE4CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

November 11, 2011

Study Completion Date

December 31, 2011

Conditions
Kidney Transplantation
Interventions
PROCEDURE

Kidney Biopsy

Skin over the kidney will be cleansed and disinfected. The skin and deeper tissue will be numbed with novocaine like solution. A special needle will be inserted guided by ultrasound into the kidney for an instant to withdraw the small specimen.

DRUG

Rapamune (sirolimus/rapamycin)

Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.

DRUG

Tacrolimus

Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months).

Trial Locations (1)

14203

Buffalo General Hospital Multi-Organ Transplant Department, Buffalo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

University of Washington

OTHER

lead

University at Buffalo

OTHER