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:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT05030168
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years at screening
* Stable CKD stage 5 not yet on dialysis with residual kidney function 5-10 ml/min/1.73m2 by CKD-EPI equation
* Urine output ≥ 800 ml/day
* Willing to participate in the study and can provide inform consent
Exclusion Criteria:
* Rapid glomerular filtration rate (GFR) progression defined as a decline of eGFR \>10 ml/min/1.73m2 by CKD-EPI equation in the prior 6 months before enrollment
* Presence of wasting diseases, cancer cachexia, tuberculosis, AIDS wasting syndrome
* Other active infection/inflammation determined by CRP \>10 mg/L
* Severe gastrointestinal problem: persistent nausea/vomiting, dysphagia, chronic diarrhea, severe malabsorption
* Conditions at baseline requiring withdrawal from the study including severe protein energy wasting by SGA and MIS score, prior kidney transplantation with immunosuppressive agents or other serious medical conditions.
* Pregnancy
* Uncontrolled hypercalcemia (persistent serum Ca ≥10.5 mg/dl)
* BMI ≥ 35 kg/m2
* Hypersensitivity to the active substances or to any of the excipients of Ketosteril
* Disturbed amino acid metabolism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05030168
Study Brief:
Protocol Section:
NCT05030168