drugset / Trial / NCT03959228

Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production

NCT03959228 ↗

Phase 3 Unknown 50 enrolled Hospices Civils de Lyon
RandomizedParallel-groupOpen-labelTreatment

Summary

Chronic kidney disease (CKD) is associated with accumulation of uremic toxins like p-cresyl sulfate and indoxyl sulfate that are associated of cardiovascular complication and perturbation of glucose metabolism. These toxins are produced by fermentation of protein by intestinal microbiota but the role of low protein diet and ketoanalogue supplementation on uremic toxins production and microbiota composition are unknown. Low protein diet supplemented with ketoanalogues is recommended inCKD patients to prevent progression of renal disease. The aim of this study is to determine the impact of uremic toxins concentration, microbiota composition and gut hormone involved in carbohydrate metabolism ( GLP-1, FGF19, bile acids) with low protein diet supplemented with ketoanalogues.

Timeline

Start
2019-11-12
Primary completion
2023-12-12
Completion
2023-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject keto-analogs Unknown 1 unknown —

Indications