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NCT00481481 Clinical Trial

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

Transplantation Clinical Trial

— CONCERTO  

Official title:
A Multicenter, Single-arm, Open, Conversion Study From a Cyclosporine (CyA) Based Immunosuppressive Regimen to a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481481
Other study ID # PMR-EC-1209
Secondary ID
Status Completed
Phase Phase 3
First received May 30, 2007
Last updated July 17, 2014
Start date April 2007
Est. completion date April 2009

Study information
Verified date July 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Ministry for Health and WomenBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Ministry of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencySwitzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

Description:

Multicenter, single-arm, open phase IIIb, conversion study where a Cyclosporine A-based immunosuppressive regimen is replaced by the administration of tacrolimus modified release formulation, MR4, once daily (morning dosing only) in stable renal transplant subjects. The initial recommended dose of MR4 is 0.1 mg/kg/day.

Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects, hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension.

Stable, adult kidney transplant recipients (≥ 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled.

Recruitment information / eligibility
Status Completed
Enrollment 346
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Serum creatinine < 200 µmol/l (< 2.3 mg/dl) at enrollment.

- Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.

- Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).

Exclusion Criteria:

- Previously received an organ transplant other than a kidney.

- Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy

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

Austria,  Belgium,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Poland,  Spain,  Sweden,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in creatinine clearance, calculated according to Cockcroft and Gault formula. Week 24 No
Secondary Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall Week 24 No
Secondary Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) Week 24 No
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