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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359658

Enrollment

Registered

2006-08-02

Start date

2004-11-30

Completion date

2008-06-30

Last updated

2009-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Transplantation

Keywords

Cyclosporine, Glucocorticoids, renal insufficiency, chronic, long-term care

Brief summary

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.

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.

Interventions

DRUGprednisolon

prednisolon withdrawal: reduction of maintenance dosage, 0,5 mg of the daily dose every week till withdrawal

DRUGMycophenolatmofetile

Mycophenolatmofetile administration: start doses 250 mg, increase of the daily dose about 250 mg every week till reaching 2 g/daily

DRUGCyclosporin 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Renal function evaluated by serum creatinine at month 12 and month 24	month 12 and month 24

Secondary

Measure	Time frame
Cardiovascular risk factors at 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	month 12 and month 24
Quality of life assessed by the SF36, spiroergometry, concomitant medication at month 12 and month 24	month 12 and month 24

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026