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

NCT00359658 | Completed

• 1 other identifier: KKS-94/2004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Renal function evaluated by serum creatinine at month 12 and month 24

  month 12 and month 24

Secondary Outcomes (3)

• 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

Study Arms (1)

1

EXPERIMENTAL

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; Drug: Mycophenolatmofetile; Drug: Cyclosporin A

Interventions

prednisolon DRUG

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

Also known as: Decortin, steroid withdrawal

1

Mycophenolatmofetile DRUG

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

Also known as: MMF, Cellcept

1

Cyclosporin A DRUG

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

Also known as: Sandimmun optoral

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

Hanover, 30625, Germany

Location

Related Publications (1)

• Faulhaber M, Mading I, Malehsa D, Raggi MC, Haverich A, Bara CL. Steroid withdrawal and reduction of cyclosporine A under mycophenolate mofetil after heart transplantation. Int Immunopharmacol. 2013 Apr;15(4):712-7. doi: 10.1016/j.intimp.2013.02.012. Epub 2013 Feb 28.

  PMID: 23454241 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Prednisone; Mycophenolic Acid; Cyclosporine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Christoph Bara, Dr. med.

  Hannover Medical School, Department of Thoracic and Cardiovascular Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2006
• First Posted: August 2, 2006
• Study Start: November 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

DE (1)