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Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction After Heart Transplantation

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00359814
First received: August 1, 2006
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of this study is to improve or save renal function by optimizing the immunosuppressive regimen by reducing the Cyclosporine A dose and the exchange of Azathioprine by Mycophenolatmofetile, which is an effective immunosuppressive agent and will minimize the risk of acute rejection episodes.


Condition Intervention
Heart Transplantation
 Drug: Mycophenolatmofetile
Drug: Cyclosporin A

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: Conversion Study to Optimize Immunosuppressive Regimen by Exchange of Azathioprine by Mycophenolatmofetile and Cyclosporine A Dose Reduction for Patients After Heart Transplantation in Lon-Term

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Renal function evaluated by serum creatinine at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: Yes ]
  • Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
  • Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: November 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Azathioprine administration: was stopped at day 0; Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily; Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
 Drug: Mycophenolatmofetile
Mycophenolatmofetile administration: was started with 250 mg/daily at day 1, the start dose was increased about 250 mg/daily every week till 2 g/daily
Other Names:
  • MMF
  • CellCept
Drug: Cyclosporin A
Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 50 to 90 ng/ml
Other Name: Sandimmun optoral

Detailed Description:

The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects.Long-term administration of calcineurin inhibitors is associated with chronic nephrotoxicity.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current immunosuppressive regimen: Cyclosporine A, Azathioprine and corticosteroids for at least 12 month
  • Heart transplantation above 3 years dated back
  • Serum creatinine < 3,5 mg/dl (310 µmol/l) and BUN < 150 mg/dl
  • Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

Exclusion Criteria:

  • Carcinoma within the last 3 years
  • Acute rejection episodes during the last 6 month
  • Infection requiring therapeutic intervention
  • Hepatitis B, Hepatitis C or HIV infection
  • WBC < 3000/µl, haemoglobin < 9g/dl, platelets < 70.000/µl
  • Florid gastrointestinal ulcer
  • Haemodialysis within the last 4 weeks before study entry
  • Pregnancy / lactation
  • Administration of other immunosuppressive agents than prescribed
  • Mycophenolatmofetile incompatibility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359814

Locations
Germany
Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Hoffmann-La Roche
Investigators
Study Director: Christoph Bara, Dr. med. Hannover Medical School, Department of Thoracic and Cardiovascular Surgery
  More Information

No publications provided

Responsible Party: Dr. med. Christoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
ClinicalTrials.gov Identifier: NCT00359814     History of Changes
Other Study ID Numbers: KKS-95/2004
Study First Received: August 1, 2006
Last Updated: February 13, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hannover Medical School:
Cyclosporine
renal insufficiency, chronic
long-term care

Additional relevant MeSH terms:
Azathioprine
Cyclosporins
Cyclosporine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on June 17, 2013