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Baking soda study for kidney patients pulled before it started

NCT ID NCT03301558

Disease control Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study was designed to see if taking sodium bicarbonate (a common antacid) could reduce the risk of harmful calcium buildup in the blood vessels of kidney transplant recipients. It planned to give participants either a low or high dose of sodium bicarbonate and measure changes in blood calcification. However, the trial was withdrawn before any patients were enrolled, so no results are available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sodium bicarbonate (Nephrotrans)
What this could lead to
If it had succeeded, this could have pointed toward a simple way to reduce blood vessel calcification in kidney transplant patients.
What could go wrong
The trial was withdrawn before enrolling anyone, so no data exist. Even if run, it was a small early-phase study that might not have shown a clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

Dec 2025

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplant; complications

Contacts and locations

Locations

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, Upper Austria, 4020, Austria

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