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 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT06836206
Eligibility Criteria:
Inclusion Criteria:
To be eligible to participate in this trial, an individual must meet all the following criteria:
1. Men and women ≥18 years of age with diagnosed ESRD and prescribed regular dialysis at least once a week, weekly at least for past two weeks.
2. For past two weeks including women of childbearing potential who are currently adopting any method of contraception or have completed the family and undergone sterilization procedures and women of non-childbearing potential.
3. Patients with residual renal function - Patients who produce a minimum of 200 ml of urine during a full day of collection (A full day collection: the patient discards the first urine sample on the day of collection then collects all urine for the entire day and night and collects the first urine sample of the next day) r on a non-dialysis long break day.
4. Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
5. With the ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.
Exclusion Criteria:
1. Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
2. Women Pregnant or lactating
3. Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
4. Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
5. Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
6. Peritoneal dialysis.
7. Kidney transplant or booked for a live transplant within 259 days of randomization.
8. Patients gaining \>4 kg between dialysis sessions in the past 2 weeks.
9. People with known allergies to quillaja bark or similar tree bark.
10. Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).
11. Patients on immunosuppression for kidney transplant.
Additional exclusion criteria for follow-up visits.
1. Patient informs of pregnancy.
2. Severe adverse reaction to the interventional product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06836206
Study Brief:
Protocol Section:
NCT06836206