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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT02472834
Eligibility Criteria:
Inclusion Criteria:
* Informed of the investigational nature of the study and sign written informed consent
* Willing and able to adhere to all study-related procedures, including adherence to study medication regimen
* ≥18 years old
* On stable medical therapy in the last 30 days before the study entry, defined as no change, addition, or removal of medications
* Patients must satisfy the following criteria based on the initial screening laboratory values:
* Serum albumin ≥ 3.0 g/dL (30 g/L)
* Dialysis adequacy recorded as Kt/ V \> 1.2
* Carbamylated albumin (C-Alb) \> 7.7 mmol/mol
* Women of childbearing potential must be practicing barrier or oral contraception, for the duration of the study-related treatment, or be documented as surgically sterile or one year post-menopausal
* If female, be non-nursing, non-pregnant and have a negative pregnancy test within two weeks of starting study treatment
* On stable hemodialysis therapy for at least 90 days before the study entry, defined as receiving thrice weekly dialysis and carrying a diagnosis of ESRD
* Prescribed a dialysis treatment time of 4 hours per session
Exclusion Criteria:
* Taking any type of amino acid supplementation within the last 90 days
* Received parenteral nutrition within last 90 days
* History of allergy to any amino acid compound
* Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg during any of the previous 3 dialysis sessions (confirmed by repeat)
* Severe hepatic impairment
* HIV positive
* Condition with prognosis \<1 year at time of study entry
* Body Mass Index (BMI) \<18 or \>30
* Current active treatment in another investigational study or participation in another investigational study in the 1 month prior to screening
* Active malignancies or other serious concurrent or recent medical or psychiatric condition which, in the opinion of the Investigator, makes the patient unsuitable for participation in this study
* Presence of asthma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02472834
Study Brief:
Protocol Section:
NCT02472834