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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359814

Enrollment

Registered

2006-08-02

Start date

2004-11-30

Completion date

2008-06-30

Last updated

2009-02-16

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

Conditions

Heart Transplantation

Keywords

Cyclosporine, renal insufficiency, chronic, long-term care

Brief summary

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.

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.

Interventions

DRUGMycophenolatmofetile

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

DRUGCyclosporin A

Cyclosporin A reduction: Cyclosporin A trough level reduction started after week 8. The new target range was 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, 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

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
acute rejection episodes, gastrointestinal disorders and other adverse events at month 12 and month 24	month 12 and month 24
Cardiovascular risk factors 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