Renal FailurePhase 3KETO-GUTNCT03959228
Impact of Low Protein Diet Supplemented With Ketoanalogues Supplementation on Uremic Toxins Production
A Phase 3 study testing keto-analogs in people with Renal Failure, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- keto-analogs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to 12 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD stage 4-5 with estimated glomerular filtration rate < 30 ml/min/1,73m2
- No dialysis
- No history of kidney transplantation
- Non-diabetic (fasting glucose <1.26 g / L, or no insulin or oral antidiabetic therapy)
- BMI between 18 and 30 kg / m2
- Patient followed in the nephrology department of Professor FOUQUE at the Lyon Sud hospital
- For women of childbearing age, at least one method of contraception recognized as effective
- Patient who gave consent to open participation and signed the consent to participate in the study
Who cannot join
- Patient with progressive inflammatory, infectious, cardiovascular or neoplastic disease
- Patient refusing a dietary follow-up
- Patient having a planned transplant or dialysis project in the next 6 months.
- Patient having a colectomy, resection of the small intestine or cholecystectomy
- Patient who has received antibiotics, prebiotics, probiotics in the last 3 months.
- Patient treated with more than 2 g of calcium per day
Show all 18Show fewer
- Patient using laxatives (more than 2 per day)
- Patient having:
- Uncontrolled metabolic acidosis (bicarbonatemia <18 mM)
- Hyperparathyroidism (PTH greater than 5 times the upper limit of normal)
- Hypercalcemia (Calcium> 2.55 mmol / L) or hypophosphoremia <0.70 mmol / L
- Anemia (hemoglobinemia <80g / L)
- Undernutrition criteria: albumin <38 g / L or prealbumin <0.3 g / L
- Known hypersensitivity to any of the substances or excipients of Ketosteril
- Subject in exclusion period of a previous study
- Patient not affiliated to social security
- Patient under guardianship or in the interests of justice
- Patient who is pregnant, breastfeeding or likely to become pregnant during the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon SUD
Pierre-Bénite, 69310
Laetitia KOPPE, PhD, 04 72 67 87 15 ext. +33, laetitia.koppe@chu-lyon.fr
Denis FOUQUE, PhD
About this study
Official title: Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease
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.
- Conditions
- Renal Failure
- Being tested
- keto-analogs
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
keto-analogsDrug
The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).
| Study group | Role | What they receive |
|---|---|---|
| referencial diet | No intervention | 0.8 g/kg/day of protein |
| protein very poor diet with additional keto-analogs | Experimental | 0.4 g/kg/day of protein and 1 pill of Ketosteril/ 5kg. Receives: Drug: keto-analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoxyl Sulfate Plasmatic concentration
Concentration mesure of Indoxyl Sulfate Plasmatic
Measured: After 3 months of diet
Secondary outcomes (13)
TMAO uremic toxin concentraction ( TMAO, PCS) in plasma
concentration mesure of uremic toxin in plasma
Measured: After 3 months
TMAO uremic toxin concentraction in urine ( IS, PCS)
concentration mesure of uremic toxin in urine
Measured: After 3 months
Composition of intestinal microbiota
sequencing 16s stool samples
Measured: Before three months
Composition of intestinal microbiota
sequencing 16s stool samples
Measured: After three months
Insulin sensitivity
oral glucose tolerance test
Measured: After 3 months
Insulin secretion
oral glucose tolerance test
Measured: After 3 months
Secretion of gut hormone like GLP-1 and FGF19
oral glucose tolerance test
Measured: After 3 months
Composition of bile acid
composition of bile acid mesure by chromatography
Measured: After 3 months
Concentration of bile acid
concentration of bile acid mesure by Chromatography
Measured: After 3 months
Concentration of endotoxinemia (LPS)
LPS concentration mesure
Measured: After 3 months
Nutritional status
Nutrional status will be determined with body weight, body composition with bioimpedecemetry, albumin, prealbumin, muscle status with hand grip.
Measured: After 3 months
Calcemia
calcemia mesure
Measured: After 3 months
Observance of diet
counting of returned ketosteril tablets
Measured: After 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start12 Nov 2019
- Primary completion12 Dec 2023 (estimated)
- Study completion12 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959228
- Sponsor's protocol ID
- 69HCL18_0957
- Acronym
- KETO-GUT
- Status last verified
- Jul 2021
- First submitted
- 25 Apr 2019
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Protein Diet Supplemented With Ketoanalogues on Uremic Toxins Production and Glucose Metabolism in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03959228
- Acronym / sponsor ID
- KETO-GUT / 69HCL18_0957
- Conditions
- Renal Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 12 Dec 2023 (estimated)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| referencial diet | No intervention | –0.8 g/kg/day of protein |
| protein very poor diet with additional keto-analogs | Experimental | Drug: keto-analogs0.4 g/kg/day of protein and 1 pill of Ketosteril/ 5kg. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CKD stage 4-5 with estimated glomerular filtration rate < 30 ml/min/1,73m2
- No dialysis
- No history of kidney transplantation
- Non-diabetic (fasting glucose <1.26 g / L, or no insulin or oral antidiabetic therapy)
- BMI between 18 and 30 kg / m2
Key exclusion criteria (18 listed)
- Patient with progressive inflammatory, infectious, cardiovascular or neoplastic disease
- Patient refusing a dietary follow-up
- Patient having a planned transplant or dialysis project in the next 6 months.
- Patient having a colectomy, resection of the small intestine or cholecystectomy
- Patient who has received antibiotics, prebiotics, probiotics in the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| keto-analogsThe patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg). | Drug | protein very poor diet with additional keto-analogs |
Primary outcome
Indoxyl Sulfate Plasmatic concentration
Time frame: After 3 months of diet
Concentration mesure of Indoxyl Sulfate Plasmatic
13 secondary outcomes
TMAO uremic toxin concentraction ( TMAO, PCS) in plasma
Time frame: After 3 months
TMAO uremic toxin concentraction in urine ( IS, PCS)
Time frame: After 3 months
Composition of intestinal microbiota
Time frame: Before three months
Composition of intestinal microbiota
Time frame: After three months
Insulin sensitivity
Time frame: After 3 months
Insulin secretion
Time frame: After 3 months
Secretion of gut hormone like GLP-1 and FGF19
Time frame: After 3 months
Composition of bile acid
Time frame: After 3 months
Concentration of bile acid
Time frame: After 3 months
Concentration of endotoxinemia (LPS)
Time frame: After 3 months
Nutritional status
Time frame: After 3 months
Calcemia
Time frame: After 3 months
Observance of diet
Time frame: After 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing keto-analogs in people with Renal Failure, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laetitia KOPPE, MD (+33 4 72 67 87 15 ext. +33, Laetitia.koppe@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indoxyl Sulfate Plasmatic concentration (time frame: After 3 months of diet). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.