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Can a pill replace the needle for anemia in diabetic kidney disease?

NCT ID NCT07786168

Disease control Sponsor: Hanzla Arshad 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This trial tests whether an oral drug called roxadustat can treat anemia in people with diabetic nephropathy and chronic kidney disease as effectively as the standard erythropoietin injections. About 64 adults aged 18 to 75 will receive either roxadustat pills three times a week or erythropoietin injections twice a week for three months. The main goal is to see how much hemoglobin levels rise in each group, with a secondary focus on how many people achieve a meaningful increase.

What this could mean

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

Active substance
Roxadustat (oral pill) compared with erythropoietin (injection)
What this could lead to
If roxadustat works as well as or better than erythropoietin, it could offer a more convenient pill-based option for managing anemia in diabetic kidney disease.
What could go wrong
This is a small, early-stage trial with only 64 participants, so results may not apply broadly. Roxadustat may carry risks like blood pressure changes or blood clots, and it may not outperform the standard injection.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

64 people

The number who actually took part.

Started

Dec 2025

Finished

Jun 2026

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 to 75 years

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: Age 18 to 75 years. Confirmed type 1 or type 2 diabetes mellitus. Chronic kidney disease stage 3a, 3b, 4, or 5, based on estimated glomerular filtration rate calculated using the 2021 CKD-EPI creatinine equation. Anaemia, defined as haemoglobin \<13.0 g/dL in males and \<12.0 g/dL in females. Treatment-naive to erythropoiesis-stimulating agents or no erythropoiesis-stimulating agent treatment during the previous 4 weeks. Exclusion Criteria: Blood transfusion within the previous 8 weeks. Active infection. Malignancy. Active inflammatory disease. History of thromboembolic events. Uncontrolled hypertension. Pregnancy or breastfeeding. Known hypersensitivity to roxadustat or erythropoietin. Participation in another interventional study within the previous 30 days.

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Conditions

The condition(s) this trial relates to.

anemia chronic kidney disease chronic renal failure syndrome diabetic kidney disease

As listed by the trial registrant

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

Anemia Chronic kidney disease Diabetic nephropathy

Contacts and locations

Locations

  • Sheikh Zayed Hospital

    Lahore, 54810, Pakistan

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