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 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT03301558
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥ 18 years old
* Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients
* eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²
* Patient has provided informed consent prior to initiation of any study related procedure
Exclusion Criteria:
* Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).
* Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment…) as judged by the recruiting physician
* Pregnant and nursing (lactating) women
* Unwillingness to discontinue current medication with sodium bicarbonate
* Unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03301558
Study Brief:
Protocol Section:
NCT03301558