Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT03959228
Eligibility Criteria:
Inclusion Criteria:
* 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
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:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03959228
Study Brief:
Protocol Section:
NCT03959228