The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcif... | NCT03301558

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

due to organizational reason

Expanded Access Info

Start Date

Dec 31, 2025Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Sep 28, 2017

First Submission Date that Met QC Criteria

Oct 3, 2017

First Posted Date

Oct 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Name	Class
Medice Arzneimittel Pütter GmbH & Co KG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Low dose sodium bicarbonate	Drug	1500 mg sodium bicarbonate	Low dose sodium bicarbonate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Serum bicarbonate levels	The secondary outcome is change of serum bicarbonate levels between different study phases.	12 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniela Cejka, MD	Head of Nephrology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ordensklinikum Linz GmbH Elisabethinen		Linz	Upper Austria	4020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

Intervention Model Description

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic
D007287	Inorganic Chemicals
D017670	Sodium Compounds