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NCT Number: NCT01752738

Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Björn Meijers, MD, PhD

PRINCIPAL_INVESTIGATOR

Ruben Poesen, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage change in number of intestinal drug transporters and enzymes

    Time frame: 4 years

    Influence of chronic kidney disease on intestinal drug transporters and enzymes responsible for uptake and metabolism of microbial metabolites

Study contacts

Contact information is provided by the study sponsor or research team.

Bjorn Meijers, MD, PhD

CONTACT

[email protected]

+32 16 344 580

Sander Derjongh

CONTACT

[email protected]

+ 32 16 342352

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

The Influence of Chronic Kidney Disease on Intestinal Transport of Gut Microbial Metabolites

Important dates

Study start
2013
Primary completion
2021
Study completion
2025
First posted
Dec 19, 2012
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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