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Clinical Trial Details

Trial ID: L0436
Source ID: NCT00776191
Associated Drug: Physioneal 35
Title: Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism
Acronym: NephropaedPD01
Status: TERMINATED
Study Results: NO
Results:
Conditions: Endstage Renal Disease
Interventions: DRUG: Physioneal 35|DRUG: Physioneal 40
Outcome Measures: Primary: To demonstrate an increase in protein metabolism during treatment with Physioneal 35® compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis., 16 weeks | Secondary: To demonstrate a improved Fat oxidation during treatment with Physioneal compared to treatment with Physioneal 40® in children and adolescents with end stage renal failure receiving peritoneal dialysis., 16 weeks
Sponsor/Collaborators: Sponsor: University of Erlangen-Nürnberg Medical School
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE4
Enrollment: 5
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-09
Completion Date: 2012-05
Results First Posted:
Last Update Posted: 2015-06-04
Locations: Pediatric Nephrology, Universiy Children's Hospital, Cologne, Germany|Dept. of Pediatric Nephrology, University Hospital Erlangen, Erlangen, Germany|Dept. of Pediatric Nephrology, University of Hannover, Hannover, 30625, Germany|Dept. of Nephrology, children´s hospital Memmingen, Memmingen, 87700, Germany|Dept. of Nephrology, University of Rostock, Rostock, 18057, Germany
URL: https://clinicaltrials.gov/show/NCT00776191