Overview

This trial is active, not recruiting.

Condition chronic kidney disease
Sponsor Universitaire Ziekenhuizen Leuven
Start date December 2013
End date December 2016
Trial size 20 participants
Trial identifier NCT01752738, S54909

Summary

Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms governing their intestinal uptake and metabolism, however, are currently unknown. The investigators aim to explore these transport characteristics in depth. Therefore, colonic biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to available data of healthy controls. Insights in the mechanisms controlling intestinal transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it might lead to novel therapeutic targets in the treatment of chronic kidney disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Percentage change in number of intestinal drug transporters and enzymes
time frame: 4 years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: - Age ≥ 18 and ≤ 85 years - Chronic kidney disease ≤ stage III (KDOQI), i.e., estimated glomerular filtration rate (MDRD) < 60 ml/min/m² or need of dialysis therapy 27 - Scheduled colonoscopy for diagnostic purposes - Written informed consent Exclusion Criteria: - History of gastro-intestinal disease (e.g., inflammatory bowel disease) - History of colon surgery - Recipient of a renal or other solid organ transplant - Exposure to antibiotics or drug therapy with a known influence on intestinal transporters (e.g., P-gp) or enzymes during 2 weeks before colonoscopy

Additional Information

Official title The Influence of Chronic Kidney Disease on Intestinal Transport of Gut Microbial Metabolites
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.