The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Tr… (NCT03301558) | Clinical Trial Compass
WithdrawnPhase 2
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Stopped: due to organizational reason
Austria0Started 2025-12-31
Plain-language summary
This is a single-center, prospective, open-label, randomized, cross-over study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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