Impact of low protein diet supplemented with ketoanalogues on uremic toxins production and glucose metabolism in chronic kidney disease_KETO GUT study

Phase 1

• Conditions: chronic kidney disease; MedDRA version: 20.0Level: LLTClassification code 10076412Term: Chronic kidney disease stage 5System Organ Class: 100000004857; MedDRA version: 20.0Level: LLTClassification code 10076411Term: Chronic kidney disease stage 4System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-002225-30-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-05
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

- Age between 18 and 80 years
-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-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
-Patient using laxatives (more than 2 per day)
-Patient having:
o Uncontrolled metabolic acidosis (bicarbonatemia <18 mM)
o Hyperparathyroidism (PTH greater than 5 times the upper limit of normal)
o Hypercalcemia (Calcium> 2.55 mmol / L) or hypophosphoremia <0.70 mmol / L
o Anemia (hemoglobinemia <80g / L)
o 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
--atient under guardianship or in the interests of justice
-Patient who is pregnant, breastfeeding or likely to become pregnant during the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified