Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects (CONCERTO)
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00481481
First received: May 30, 2007
Last updated: May 12, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Transplantation |
Drug: tacrolimus |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A MULTICENTER, SINGLE-ARM, OPEN, CONVERSION STUDY FROM A CYCLOSPORINE (CyA) BASED IMMUNOSUPPRESSIVE REGIMEN TO A TACROLIMUS MODIFIED RELEASE, FK506MR, BASED IMMUNOSUPPRESSIVE REGIMEN IN KIDNEY TRANSPLANT SUBJECTS |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Change in creatinine clearance, calculated according to Cockcroft and Gault formula. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 346 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tacrolimus
immunosuppression
Other Names:
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481481
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Hide Study LocationsLocations
| Austria | |
| Innsbruck, Austria | |
| Linz, Austria | |
| Vienna, Austria | |
| Belgium | |
| Brussels, Belgium | |
| Edegem, Belgium | |
| Leuven, Belgium | |
| Liege, Belgium | |
| Roeselare, Belgium | |
| Czech Republic | |
| Olomouc, Czech Republic | |
| Prague, Czech Republic | |
| Denmark | |
| Aarhus, Denmark | |
| Finland | |
| Helsinki, Finland | |
| France | |
| Bordeaux, France | |
| Brest, France | |
| Paris, France | |
| Pierre-Benite, France | |
| Strasbourg, France | |
| Toulouse, France | |
| Tours, France | |
| Vandoeuvre, France | |
| Germany | |
| Berlin, Germany | |
| Cologne, Germany | |
| Essen, Germany | |
| Halle, Germany | |
| Hannover, Germany | |
| Heidelberg, Germany | |
| Leipzig, Germany | |
| Lubeck, Germany | |
| Munich, Germany | |
| Tubingen, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Debrecen, Hungary | |
| Italy | |
| Bologna, Italy | |
| Cagliari, Italy | |
| Firenze, Italy | |
| Genova, Italy | |
| L'Aquila, Italy | |
| Milano, Italy | |
| Modena, Italy | |
| Napoli, Italy | |
| Padova, Italy | |
| Treviso, Italy | |
| Udine, Italy | |
| Poland | |
| Gdansk, Poland | |
| Lublin, Poland | |
| Poznan, Poland | |
| Warsaw, Poland | |
| Spain | |
| Alicante, Spain | |
| Badajoz, Spain | |
| Barakaldo, Spain | |
| Madrid, Spain | |
| Oviedo, Spain | |
| Palma de Mallorca, Spain | |
| Salamanca, Spain | |
| Sweden | |
| Lund, Sweden | |
| Switzerland | |
| Zurich, Switzerland | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Director: | Central Contact | Astellas Pharma GmbH |
More Information
No publications provided by Astellas Pharma Inc
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
| ClinicalTrials.gov Identifier: | NCT00481481 History of Changes |
| Other Study ID Numbers: | PMR-EC-1209 |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 12, 2009 |
| Health Authority: | Austria: Federal Ministry for Health and Women Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Poland: Ministry of Health Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic |
Keywords provided by Astellas Pharma Inc:
|
Tacrolimus, Kidney Transplantation |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Immunosuppressive Agents Tacrolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Immunologic Factors Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013