Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00359658
First received: August 1, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.


Condition Intervention
Heart Transplantation
Drug: prednisolon
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 Withdrawal of Steroids, Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term.

Resource links provided by NLM:


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:
  • Cardiovascular risk factors at month 12 and month 24 [ Time Frame: month 12 and month 24 ] [ Designated as safety issue: No ]
  • 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 ]
  • 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: 40
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
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal; Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily; Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 50 to 90 mg/ml
Drug: prednisolon
prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal
Other Names:
  • Decortin
  • steroid withdrawal
Drug: Mycophenolatmofetile
Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily
Other Names:
  • MMF
  • Cellcept
Drug: Cyclosporin A
Cyclosporin A reduction: 8 weeks after starting prednisolon withdrawal and Mycophenolatmofetile administration reduction of Cyclosporin A trough level till a range from 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. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.

  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 and corticosteroids for at least six 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: NCT00359658

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 by Hannover Medical School

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. med. Chhristoph Bara, Clinic for Cardiothoracic, Transplantation and Vascular Surgery, HannoverMS
ClinicalTrials.gov Identifier: NCT00359658     History of Changes
Other Study ID Numbers: KKS-94/2004
Study First Received: August 1, 2006
Last Updated: February 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014