Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:2/23/2019
Start Date:February 24, 2003
End Date:October 7, 2009

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Trial Summary
Trial Overview
Inclusion Criteria

A Long-term Follow up Study to Evaluate the Safety and Efficacy in Transplant Recipients Treated With Modified Release Tacrolimus, FK506E (MR4), Based Immunosuppression Regimen

The purpose of this study was to offer patients who had participated in one of the phase II
PK or phase III studies on FK506E (MR4) the possibility to continue FK506E (MR4) until
commercial availability of the drug and to record long term efficacy and safety data.

The objective of this study was to asses the safety and efficacy of FK506E (MR4) as a
long-term treatment in transplant recipients. Only patients who had participated in one of
the phase II PK or phase III studies on FK506E (MR4) and had received at least one dose of
study medication were enrolled.

Inclusion Criteria:

- Patients who had already participated in the previous phase II pharmacokinetic or
phase III studies with FK506E (MR4).

- Patients capable of understanding the purpose and risks of the study, who had been
fully informed and given written informed consent to participate in the study.

Exclusion Criteria:

- Pregnant women or nursing mothers.

- Women unwilling or unable to use adequate contraception during the study.
We found this trial at
2
sites
The University Hospital
Cincinnati, Ohio 45219
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from
Cincinnati, OH
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Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
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from
Camperdown,
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