drugset / Trial / NCT00776191

Randomized Multicenter Cross-over Study to Compare the Effect of Physioneal 35 to 40 on the Protein Metabolism

NCT00776191 ↗

Phase 4 Terminated 5 enrolled University of Erlangen-Nürnberg Medical School
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to demonstrate an increase in protein metabolism during treatment with Physioneal 35® (containing lactate 10 mmol/l, calcium 1.75 mmol/l) compared to treatment with Physioneal 40® (containing lactate 15 mmol/l, calcium 1.25 mmol/l) in children and adolescents with end stage renal failure receiving peritoneal dialysis.

Timeline

Start
2008-09
Primary completion
2012-05
Completion
2012-05

Outcome

Outcome not reported

Stopped: “al study sites stoped on 15/05/2012 because of insufficient recrutement.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Physioneal 35 Unknown — —
Comparator Physioneal 40 Unknown — —