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 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT04086212
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) for at least 3 months
* A stable clinical condition during the two weeks immediately prior to randomization
* Blood hemoglobin concentration above 8,5 g/100ml
* Has not experienced peritonitis episodes in the last 3 months
* Treated with Extraneal for at least 1 month
* Peritoneal Equilibration Test (PET) performed in the last three months
* Has understood and signed the Informed Consent Form.
Exclusion Criteria:
* History of drug or alcohol abuse in the six months prior to entering the protocol
* Acute infectious condition
* History of severe congestive heart failure and clinically significant arrhythmia
* Malignancy within the past 5 years, including lymphoproliferative disorders
* A medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug
* A clinically relevant under-hydration as judged by the treating physician
* History of L-Carnitine therapy or use in the month before entering the study
* Received any investigational drug in the 3 months before entering the study
* Pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04086212
Study Brief:
Protocol Section:
NCT04086212