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

February 12, 2009 updated by: Hannover Medical School

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Cellcept
  • MMF
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 Names:
  • Sandimmun optoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function evaluated by serum creatinine at month 12 and month 24
Time Frame: month 12 and month 24
month 12 and month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular risk factors at month 12 and month 24
Time Frame: month 12 and month 24
month 12 and month 24
Acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24
Time Frame: month 12 and month 24
month 12 and month 24
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24
Time Frame: month 12 and month 24
month 12 and month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Collaborators

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

August 1, 2006

First Submitted That Met QC Criteria

August 1, 2006

First Posted (ESTIMATE)

August 2, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KKS-94/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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