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

Phase 2

Withdrawn

• Conditions: Kidney Transplant; Complications
• Interventions: Drug: High dose sodium bicarbonate; Drug: Low dose sodium bicarbonate

• Registration Number: NCT03301558
• Lead Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka

Brief Summary

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

Detailed Description

The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.

The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.

Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.

Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07
• Study Start: 2024-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Dose sodium bicarbonate	High dose sodium bicarbonate	High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2).
Low dose sodium bicarbonate	Low dose sodium bicarbonate	Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1).

Primary Outcome Measures

Name	Time	Method
Propensity of serum for calcification	12 weeks	The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).

Secondary Outcome Measures

Name	Time	Method
Serum bicarbonate levels	12 weeks	The secondary outcome is change of serum bicarbonate levels between different study phases.

Trial Locations

Locations (1)

Ordensklinikum Linz GmbH Elisabethinen; 🇦🇹 Linz, Upper Austria, Austria