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Trial record 1 of 1 for:    NCT00123331
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Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123331
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : August 2, 2005
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Heidelberg University

Tracking Information
First Submitted Date  ICMJE July 18, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date August 2, 2005
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
Renal function after 6 months (serum creatinine, calculated creatinine clearance)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2005)
  • Survival
  • Rejection (clinical)
  • Tolerability
  • Blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
Official Title  ICMJE Rapamycin Use in CNI-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Transplantation
  • Renal Failure
Intervention  ICMJE
  • Drug: Cyclosporine discontinuation
  • Drug: Rapamycin medication
Study Arms  ICMJE Not Provided
Publications * Angermann CE, Störk S, Costard-Jäckle A, Dengler TJ, Siebert U, Tenderich G, Rahmel A, Schwarz ER, Nägele 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: July 19, 2005)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE April 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123331
Other Study ID Numbers  ICMJE HD_cardio_352/2003_dengler
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Thomas J Dengler, MD Heidelberg University
PRS Account Heidelberg University
Verification Date June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP