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Clinical Trial 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.


Clinical Trial Description

- Fat oxidation (13C-enrichment in expiration breath samples for U-C13-algae turnover)

- Growth markers (plasma levels of IgF-1, IgF-BP3, leptin)

- Biochemical markers of anabolism (plasma levels of total protein, albumin, transferrin)

- Serum thyroid function (fT3, fT4, TSH)

- Serum lipid status

- Serum markers of calcium/phosphate metabolism (PTH, calcium, ionized calcium, phosphate, alkaline phosphatase)

- Prevalence of metabolic acidosis/ alkalosis (venous sample), serum lactate

- Safety parameters (such as normalized weekly Kt/v, parameters of glucose metabolism, parameters of hepatic function, parameters of calcium-phosphate-metabolism, physical examination incl. standing height, weight, assessment of complications related to peritoneal dialysis as peritonitis, exit infections and inguinal hernia)

- Body composition (lean body mass and body fat mass/fluid) ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00776191
Study type Interventional
Source University of Erlangen-Nürnberg Medical School
Contact
Status Terminated
Phase Phase 4
Start date September 2008
Completion date May 2012

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