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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02756520
Eligibility Criteria:
Inclusion Criteria:
* written informed consent
* non-dialyzed patients with CKD
* indication for Ketosteril according to package insert (PI), including a glomerular filtration rate (GFR) \< 25 mL/min
* accepted supplemented protein-restricted diet and newly starting with Ketosteril (treatment naïve, i.e., never treated with Ketosteril before)
* adult patients ≥ 18 years
Exclusion Criteria:
* active cancer diseases
* pregnancy or breast feeding
* hypersensitivity to active substances or to any of the excipients in Ketosteril
* hypercalcaemia
* major disorder of amino acid metabolism, e.g., hereditary diseases
* participation in any clinical trial with an investigational drug within 30 days prior to start of study or during the study
* illiteracy or incapability to read or write
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02756520
Study Brief:
Protocol Section:
NCT02756520