Back to resultsRapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Primary Purpose
Heart Transplantation, Renal Failure
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cyclosporine discontinuation
Rapamycin medication
Sponsored by
About this trial
This is an interventional treatment trial for Heart Transplantation focused on measuring Heart transplantation, Renal failure, Cyclosporine, Rapamycin
Eligibility Criteria
Inclusion Criteria: Heart transplantation (> 6 months post-operation) Renal failure (serum creatinine stably > 1.7 mg/dl Cyclosporine trough blood level < 110 ng/ml Exclusion Criteria: < 18 years of age Rapamycin intolerability Active infection Pregnancy, breast feeding Major elective surgery planned in study period Thrombopenia < 100,000/ml
Sites / Locations
- Medizinische Universitätsklinik, Kardiologie
Outcomes
Primary Outcome Measures
Renal function after 6 months (serum creatinine, calculated creatinine clearance)
Secondary Outcome Measures
Survival
Rejection (clinical)
Tolerability
Blood pressure
Full Information
NCT ID
NCT00123331
First Posted
July 18, 2005
Last Updated
August 1, 2005
Sponsor
Heidelberg University
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00123331
Brief Title
Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Official Title
Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Heidelberg University
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
Detailed Description
Clinical Problem: Renal insufficiency after heart transplantation caused by cyclosporine medication was addressed. Current therapeutic approaches include cyclosporine reduction or discontinuation. It is unclear whether discontinuation of low dose cyclosporine also has a beneficial effect, i.e. is there a threshold effect for cyclosporine nephrotoxicity?
Study Design: Heart transplant patients with a moderate degree of renal failure on low dose cyclosporine were randomized to either a) no change; or b) discontinuation of cyclosporine and initiation of rapamycin immunosuppression.
Read-Out: Renal function after 6 months; tolerability; and safety were assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Transplantation, Renal Failure
Keywords
Heart transplantation, Renal failure, Cyclosporine, Rapamycin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclosporine discontinuation
Intervention Type
Drug
Intervention Name(s)
Rapamycin medication
Primary Outcome Measure Information:
Title
Renal function after 6 months (serum creatinine, calculated creatinine clearance)
Secondary Outcome Measure Information:
Title
Survival
Title
Rejection (clinical)
Title
Tolerability
Title
Blood pressure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Heart transplantation (> 6 months post-operation)
Renal failure (serum creatinine stably > 1.7 mg/dl
Cyclosporine trough blood level < 110 ng/ml
Exclusion Criteria:
< 18 years of age
Rapamycin intolerability
Active infection
Pregnancy, breast feeding
Major elective surgery planned in study period
Thrombopenia < 100,000/ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Dengler, MD
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitätsklinik, Kardiologie
City
Heidelberg
ZIP/Postal Code
D-69115
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15351162
Citation
Angermann CE, Stork S, Costard-Jackle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nagele H, Wagner FM, Haaff B, Pethig K. Reduction of cyclosporine after introduction of mycophenolate mofetil improves chronic renal dysfunction in heart transplant recipients--the IMPROVED multi-centre study. Eur Heart J. 2004 Sep;25(18):1626-34. doi: 10.1016/j.ehj.2004.06.032.
Results Reference
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Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
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