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New kidney anemia drug under Long-Term safety review

NCT ID NCT04899661

Disease control Sponsor: Bayer 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 4 times

Summary

This study tracks over 1,000 Japanese patients with renal anemia (low red blood cells due to kidney disease) who are taking molidustat tablets. Researchers are monitoring for serious side effects like blood clots, high blood pressure, and tumors, as well as checking if red blood cell counts improve. The goal is to see how safe and effective the drug is in real-world use over up to 2 years.

What this could mean

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

Active substance
Molidustat (a drug taken as a tablet to help the body make more red blood cells)
What this could lead to
If successful, this study could confirm that molidustat is a safe and effective long-term treatment for renal anemia, helping patients maintain healthy red blood cell levels.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. There are known risks including blood clots, high blood pressure, and other serious side effects that need careful monitoring.

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.

Participants

1,081 people

The number who actually took part.

Started

Aug 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants with a diagnosis of renal anemia and have been prescribed Molidustat in accordance with the product label

Ages

20 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: * Female or male participants with a diagnosis of renal anemia * Decision to initiate treatment with Molidustat was made as per investigator's routine treatment practice * Molidustat naïve participants (with including the participants treated within three months before the contracted date at each site) * Signed informed consent Exclusion Criteria: \- Contra-indications according to the local marketing authorization

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Conditions

The condition(s) this trial relates to.

anemia due to chronic disorder

As listed by the trial registrant

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

Renal anemia

Contacts and locations

Locations

  • Many locations

    Multiple Locations, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.