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

NCT03301558 | Withdrawn Phase 2

• 1 other identifier: KTR-Bic-T50
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• Propensity of serum for calcification

  The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).

  12 weeks

Secondary Outcomes (1)

• Serum bicarbonate levels

  12 weeks

Study Arms (2)

Low dose sodium bicarbonate

ACTIVE COMPARATOR

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).

Drug: Low dose sodium bicarbonate

High Dose sodium bicarbonate

ACTIVE COMPARATOR

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).

Drug: High dose sodium bicarbonate

Interventions

High dose sodium bicarbonate DRUG

3000 mg sodium bicarbonate

Also known as: Nephrotrans

High Dose sodium bicarbonate

Low dose sodium bicarbonate DRUG

1500 mg sodium bicarbonate

Also known as: Nephrotrans

Low dose sodium bicarbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prim. Priv. Doz. Dr. Daniel Cejka: lead
• Medice Arzneimittel Pütter GmbH & Co KG: collaborator

Study Sites (1)

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Interventions

Sodium Bicarbonate

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniela Cejka, MD

  Head of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nephrology

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 4, 2017
• Study Start: December 31, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 27, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)