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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: May 30, 2007
Last updated: July 17, 2014
Last verified: July 2014
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
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, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation)

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 ]

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 ]
  • Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) [ Time Frame: Week 24 ]

Enrollment: 346
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus
Other Names:
  • Advagraf
  • FK506MR
  • MR4

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00481481

  Show 56 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Central Contact Astellas Pharma GmbH
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT00481481     History of Changes
Other Study ID Numbers: PMR-EC-1209
Study First Received: May 30, 2007
Last Updated: July 17, 2014

Keywords provided by Astellas Pharma Inc:
Tacrolimus, Kidney Transplantation

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents processed this record on July 25, 2017