Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease

NCT01752738 | Recruiting

• 1 other identifier: S54909
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Percentage change in number of intestinal drug transporters and enzymes

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

  4 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the nephrology outpatient clinic and dialysis center at University Hospital Leuven, Belgium.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine, faeces

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Bjorn Meijers, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Sander Dejongh

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sander Derjongh

CONTACT

+ 32 16 342352; sander.dejongh@kuleuven.be

Bjorn Meijers, MD, PhD

CONTACT

+32 16 344 580; bjorn.meijers@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2013
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)