Freedom Study: Myfortic in Kidney Transplant Patients

Phase 3

Completed

• Conditions: Kidney Transplantation

• Registration Number: NCT00101738
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-01-12
• Study First Submitted QC: 2005-01-12
• Study First Posted: 2005-01-13
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-28
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• Males and females aged 18 to 75 years.
• Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.

Exclusion Criteria

• Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
• Kidneys from non-heart beating donors or HLA identical living related donors.
• ABO incompatibility against the donor.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Calculated glomerular filtration rate after 12 months treatment

Secondary Outcome Measures

Name	Time	Method
Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months.
Patient and graft survival after 12 months.
Incidence of AEs and SAEs after 3 and 12 months.
Blood pressure, lipids and glucose profiles after 3 and 12 months.
Percentage of patients free of steroids at 12 months

Trial Locations

Locations (44)

UCSF Kidney Transplant Service; 🇺🇸 San Francisco, California, United States

Livelink, Inc.; 🇺🇸 Tampa, Florida, United States

Loyola Medical Center; 🇺🇸 Maywood, Illinois, United States

Indiana U. Medical Center; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University Hospitals of Cleveland, Division of Nephrology; 🇺🇸 Cleveland, Ohio, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Legacy Research & Technology Ctr.; 🇺🇸 Portland, Oregon, United States

U. of Wisconsin Hospital Clinics; 🇺🇸 Madison, Wisconsin, United States

Crai Norte; 🇦🇷 San Martin, Buenos Aires, Argentina

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