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NCT00384202 Clinical Trial

A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

Transplantation Clinical Trial

Official title:
A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00384202
Other study ID # PMR-EC-1105
Secondary ID
Status Completed
Phase Phase 3
First received October 4, 2006
Last updated July 7, 2014
Start date October 2006
Est. completion date November 2007

Study information
Verified date July 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIreland: Irish Medicines BoardPoland: Ministry of HealthSpain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Description:

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Recruitment information / eligibility
Status Completed
Enrollment 112
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Liver transplant at least 12 months prior to enrollment.

- Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

- Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus
Immunosuppression

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

France,  Germany,  Ireland,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Creatinine clearance 12 weeks No
Secondary Blood pressure, HbA1c, Acute rejection episodes 12 weeks No
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