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Randomized Study to Reduce Calcineurininhibitor Toxicity in Pediatric and Adolescent Kidney Transplant Recipients

NCT00663455 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Transplant

Interventions

DRUG

Reduction of cyclosporine A (CSA)-dosing

Reduction of CSA-dosing over 4 months. Therapy control by safety parameters (serum creatinine, C2-monitoring, renal biopsy).

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Jörg Dötsch, MD · Dept. of Pediatric Nephrology, University Hospital Erlangen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-12-31
Completion
2013-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00663455 on ClinicalTrials.gov