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

NCT ID: NCT03301558

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-31

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.

Conditions

Kidney Transplant; Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Low dose sodium bicarbonate

Intervention Type: DRUG

1500 mg 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).

Group Type: ACTIVE_COMPARATOR

High dose sodium bicarbonate

Intervention Type: DRUG

3000 mg sodium bicarbonate

Interventions

Low dose sodium bicarbonate

1500 mg sodium bicarbonate

Intervention Type: DRUG

High dose sodium bicarbonate

3000 mg sodium bicarbonate

Intervention Type: DRUG

Other Intervention Names

Nephrotrans; Nephrotrans

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medice Arzneimittel Pütter GmbH & Co KG

INDUSTRY

Sponsor Role: collaborator

Prim. Priv. Doz. Dr. Daniel Cejka

OTHER

Sponsor Role: lead

Responsible Party

Prim. Priv. Doz. Dr. Daniel Cejka

Head of Nephrology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Daniela Cejka, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Nephrology

Locations

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, Austria

Countries

Austria

Other Identifiers

KTR-Bic-T50

Identifier Type: -

Identifier Source: org_study_id