The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, prospective, open-label, randomized, cross-over study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka
• Collaborator: Medice Arzneimittel Pütter GmbH & Co KG

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