NCT03959228 (KETO-GUT) is a Phase 3 clinical trial of keto-analogs in Renal Failure, sponsored by Hospices Civils de Lyon.

Who is sponsoring NCT03959228?

NCT03959228 is sponsored by Hospices Civils de Lyon.

What drugs are being tested in NCT03959228?

Interventions in NCT03959228: keto-analogs.

What condition does NCT03959228 study?

NCT03959228 studies Renal Failure.

Is NCT03959228 still recruiting?

NCT03959228 is currently status unknown. Last updated 9 July 2021.

Last reviewed 2021-07-09 · How we verify

NCT03959228: KETO-GUT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 9 July 2021

What this trial tests

Phase 3 trial testing keto-analogs in Renal Failure in 50 participants. Status unknown.

Timeline

12 November 2019

Primary endpoint
12 December 2023

12 December 2023

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	12 November 2019
Primary completion	12 December 2023
Estimated completion	12 December 2023
Sites	1 location across France

Drugs / interventions tested

keto-analogs — full drug profile →

Conditions studied

Renal Failure — all drugs for Renal Failure →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

Adults 18 to 80, any sex, with Renal Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Uremic Toxins in the Progression of Chronic Kidney Disease and Cardiovascular Disease: Mechanisms and Therapeutic Targets.
Lim YJ, Sidor NA, Tonial NC, Che A, et al · · 2021 · cited 227× · PMID 33668632 · DOI 10.3390/toxins13020142

Verify or expand the search:

Other recruiting trials for Renal Failure

Currently open trials in the same condition.

NCT07293936 — Post-Filter Hematocrit · NA · recruiting
NCT06814327 — Assessment of Organ Failure Risk Predictions in ICU · active not recruiting
NCT06203977 — Inflammation REduction to Prevent cArdiovascular Injury in Renal Disease (REPAIR) · Phase 1 · recruiting
NCT06142396 — Pilot Study Dara-CyBorD in Newly Diagnosed Multiple Myeloma Patients With Renal Failure · EARLY_PHASE1 · recruiting
NCT06620523 — Prevent Cardiac Surgery Associated AKI Trial · Phase 2 · recruiting

Other Hospices Civils de Lyon trials

Trials by the same sponsor.

NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03959228 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospices Civils de Lyon
Last refreshed: 9 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03959228.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing