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

Kidney Transplant; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03301558
• Other study ID #: KTR-Bic-T50
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Elisabethinen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Kidney Transplant; Complications

Intervention

Drug:
• Low dose sodium bicarbonate
1500 mg sodium bicarbonate
• High dose sodium bicarbonate
3000 mg sodium bicarbonate

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH Elisabethinen	Linz	Upper Austria

Sponsors (2)

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

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum bicarbonate levels	The secondary outcome is change of serum bicarbonate levels between different study phases.	12 weeks