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Sponsored by: |
University of Erlangen-Nürnberg |
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Information provided by: | University of Erlangen-Nürnberg |
ClinicalTrials.gov Identifier: | NCT00663455 |
The purpose of this study is to determine if a safe reduction of cyclosporine A in pediatric and adolescent patients with stable renal graft function, reduces signs of calcineurin-inhibitor toxicity.
Condition | Intervention | Phase |
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Kidney Transplant |
Drug: Reduction of CSA-dosing |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Parallel-Group, Trial to Reduce Toxicity of Calcineurininhibitor-Therapy in Steroid-Free Longterm Immunosuppression in Pediatric and Adolescent Kidney Transplant Recipients |
Estimated Enrollment: | 50 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A
Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).
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Drug: Reduction of CSA-dosing
Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).
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B: No Intervention
Standard CSA-dosing without reduction. Therapy control by C2-monitoring.
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Chronic transplant nephropathy is one of the major causes of graft loss after renal transplantation. Toxicity of calcineurin-inhibitors is suspected to be one cause for loss of graft function. Therefore reduction of cyclosporine A dosing can result in longer graft survival and better graft function in patients after renal-transplantation. However, reduction of immunosuppression can result in acute rejection episodes, although it is less likely in patients with stable graft function 12 months or longer after successful renal transplantation.
Therefore the aim of this randomized, controlled study in pediatric and adolescent renal transplant recipients, is to compare the impact of reduced cyclosporine A-dosing to standard CSA-dosing on renal graft function. Therapy monitoring in both groups will be performed by obtaining CSA blood levels two hours after intake, as they provide an individual insight in pharmacokinetics in comparison to conventional trough level (C0)-measurements.
Secondary objectives to evaluate are
Ages Eligible for Study: | 3 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jörg Dötsch, MD | 49-913-185 ext 33117 | Joerg.Doetsch@uk-erlangen.de |
Germany | |
Dept. of Pediatric Nephrology, University Hospital Muenster | Not yet recruiting |
Muenster, Germany | |
Contact: Martin Konrad, MD, PhD | |
Principal Investigator: Martin Konrad, MD, PhD | |
Dept. of Pediatric Nephrology, University Hospital Heidelberg | Recruiting |
Heidelberg, Germany | |
Contact: Heiko Billing, MD | |
Principal Investigator: Heiko Billing, MD | |
Dept. of Pediatric Nephrology, University Hospital Jena | Not yet recruiting |
Jena, Germany | |
Contact: Ulrike John, MD | |
Principal Investigator: Ulrike John, MD | |
Dept. of Pediatric Nephrology, Community Hospital Memmingen | Not yet recruiting |
Memmingen, Germany | |
Contact: Henry W Fehrenbach, MD | |
Principal Investigator: Henry W Fehrenbach | |
Dept. of Pediatric Nephrology, University Hospital München | Not yet recruiting |
Munich, Germany | |
Contact: Lutz T Weber, MD | |
Principal Investigator: Lutz T Weber | |
Dept. of Pediatric Nephrology, University Hospital Erlangen | Not yet recruiting |
Erlangen, Germany | |
Contact: Joerg Doetsch, MD | |
Principal Investigator: Joerg Doetsch, MD | |
Dept. of Pediatric Nephrology, University Hospital Freiburg | Not yet recruiting |
Freiburg, Germany | |
Contact: Martin Pohl, MD | |
Principal Investigator: Martin Pohl, MD | |
Dept. of Pediatric Nephrology, University Hospital Hamburg | Not yet recruiting |
Hamburg, Germany | |
Contact: Dirk E Mueller-Wiefel, MD | |
Principal Investigator: Dirk E Mueller-Wiefel, MD | |
Dept. of Pediatric Nephrology, University Hospital Rostock | Not yet recruiting |
Rostock, Germany | |
Contact: Marianne Wigger, MD | |
Principal Investigator: Marianne Wigger, MD | |
Dept. of Pediatric Nephrology, University Hospital Hannover | Not yet recruiting |
Hannover, Germany | |
Contact: Lars Pape, MD | |
Principal Investigator: Lars Pape, MD |
Principal Investigator: | Jörg Dötsch, MD | Dept. of Pediatric Nephrology, University Hospital Erlangen, Germany |
Responsible Party: | Dep. of Pediatrics, University of Erlangen-Nürnberg ( Professor Dr. Jörg Dötsch, MD ) |
Study ID Numbers: | Recaltox-1 |
Study First Received: | April 21, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00663455 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
kidney transplant recipients children and adolescents with kidney transplants |