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Could a pill replace needles for anemic kids with kidney disease?

NCT ID NCT05970172

Disease control Sponsor: Astellas Pharma Global Development, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This phase 3 trial tests roxadustat, an oral medication, for treating anemia in children and teenagers with chronic kidney disease. About 100 participants will take the drug three times a week for up to a year. The goal is to see if it can safely raise hemoglobin levels and offer a needle-free alternative to current treatments.

What this could mean

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

Active substance
roxadustat (Evrenzo)
What this could lead to
If successful, this could provide a convenient oral treatment option for anemia in children with chronic kidney disease, reducing the need for injections.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may be less reliable. The drug may not work as well in children as in adults, and side effects are still being studied.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Oct 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.

Ages

2 to 17 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: * Participant has a diagnosis of anemia in CKD Kidney Disease Outcomes Quality Initiative stages 3 or 4 or 5. This can include participants not on dialysis or dialysis dependent (DD) participants (including hemodialysis, peritoneal dialysis and hemodiafiltration participants). * Participants not on dialysis must have an estimated glomerular filtration rate (Schwartz formula) of \< 60 mL/min per 1.73 m\^2. * ESA-treated participants should have a screening Hb level, assessed via HemoCue, between 10.0 and 12.0 g/dL; ESA-naïve participants can have a Hb level ≤ 11 g/dL. * Participant has a ferritin level \> 100 ng/mL or a transferrin saturation (TSAT) value \> 20%. * Participant has an alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x upper limit of normal (ULN) and total bilirubin (TBL) ≤ 1.5 x ULN at enrollment visit. * Participant is treated with an ESA or is ESA-naïve, where ESA status is defined as: * ESA-treated: Participant is taking a stable dose of an ESA for at least 4 weeks prior to screening. * ESA-naïve: Participant has no prior ESA exposure OR participant's total prior ESA exposure ≤ 3 weeks within the preceding 4 weeks from screening OR participant was previously treated with and discontinued an ESA ≥ 8 weeks prior to screening. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of childbearing potential (WOCBP) * WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 4 weeks after final study intervention administration. * Female participant must agree not to breastfeed starting at screening and throughout the study and for 4 weeks post-last roxadustat dose. * Female participant must not donate ova starting at first administration of roxadustat and throughout the study period and for 4 weeks post-last roxadustat dose. * Male participants with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 4 weeks post-last roxadustat dose. * Male participants must not donate sperm during the treatment period and for 4 weeks post-last roxadustat dose. * Male participants with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 4 weeks post-last roxadustat dose. * Participant and/or participant's parent or legal guardian agrees for the participant not to participate in another interventional study while participating in the present study. Exclusion Criteria: * Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening. * Participant has any medical condition, including active, systemic or clinically significant infection which may pose a safety risk to a participant in this study, which may confound the safety or activity assessment or may interfere with study participation making the participant unsuitable for study. * Participant has a known or suspected hypersensitivity to roxadustat, related hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), or any components of the formulation used. * Participant has uncontrolled hypertension (defined as ≥ 95th percentile + 12 mm Hg or ≥ 140/90 mm Hg \[whichever is lower\] for participants \< 13 years of age and ≥ 140/90 mm Hg for participants ≥ 13 years of age measured 3 times at the same visit) in the 2 weeks prior to screening. * Participant has a known hematologic disease other than anemia secondary to renal disease,(e.g., history of sickle cell disease, sickle cell anemia, hemoglobin sickle cell disease, or hemoglobin sickle cell beta thalassemia). * Participant has untreated hypothyroidism. * Participant has severe hyperparathyroidism defined as serum parathyroid hormone (PTH) levels above 1000 pg/mL intact PTH within 4 weeks of screening. * Participant has a functioning kidney allograft. * Participant has a folate or B12 or carnitine deficiency. Acceptable if treated to normal values within 4 weeks of screening. * Participant has a known active malignancy or malignancy within 18 months before the screening visit. Radiation or chemotherapy must be completed at least 12 months before the screening visit. * Participant has a scheduled living donor organ transplantation date within 12 weeks of screening. If participant becomes eligible for a kidney transplant during study conduct, the participant should be discontinued. * Participant has a whole blood or packed red blood cells (pRBC) transfusion during the 8 weeks prior to screening. * Participant has any current condition leading to active significant blood loss in the past 4 weeks. * Participant has a diagnosis of hemolytic uremic syndrome within 12 weeks prior to screening. * Participant who has a previous diagnosis of atypical hemolytic syndrome must be relapse-free (stable hemoglobin (Hb), normal platelet count, normal serum lactate dehydrogenase, and normal haptoglobin level) for more than 12 weeks prior to screening. * Participant has a history of chronic liver disease, including comorbidity with autosomal recessive polycystic kidney disease, cystinosis, and primary hyperoxaluria. * Participant had an episode of peritonitis within 30 days of screening. * Participant has active inflammation such as glomerulonephritis flare (i.e., lupus nephritis, immunoglobulin A (IgA) nephritis, rapidly progressive glomerulonephritis, membranoproliferative glomerulonephritis, antineutrophil cytoplasmic antibodies vasculitis) requiring pulse corticosteroid treatment or induction treatment with an immunosuppressive agent (i.e., cyclophosphamide, rituximab, or another monoclonal antibody) within 6 weeks of screening visit. Receipt of monoclonal antibody or biologic for maintenance treatment of underlying condition is acceptable. * Participant has a known history of human immunodeficiency virus infection. * Participant has rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or is allergic to peanut or soya.

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Conditions

The condition(s) this trial relates to.

anemia anemia due to chronic disorder chronic kidney disease chronic renal failure syndrome

As listed by the trial registrant

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

Chronic kidney disease Renal anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    46 sites in 21 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Site BE32001

    RECRUITING

    Edegem, Belgium

  • Site BE32002

    RECRUITING

    Brussels, Belgium

  • Site BE32003

    RECRUITING

    Leuven, Belgium

  • Site BE32004

    RECRUITING

    Ghent, Belgium

  • Site BG35901

    WITHDRAWN

    Sofia, Bulgaria

  • Site CZ42001

    RECRUITING

    Prague, Czechia

  • Site CZ42002

    RECRUITING

    Brno, Czechia

  • Site DE49001

    RECRUITING

    Tübingen, Germany

  • Site DK45001

    RECRUITING

    Aarhus, 8200, Denmark

  • Site ES34003

    RECRUITING

    Esplugues de Llobregat, Spain

  • Site FI35801

    RECRUITING

    Helsinki, Finland

  • Site GB44001

    RECRUITING

    Nottingham, United Kingdom

  • Site GB44003

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Site GB44004

    RECRUITING

    Southampton, United Kingdom

  • Site GB44005

    RECRUITING

    Cardiff, United Kingdom

  • Site GB44006

    RECRUITING

    Glasgow, United Kingdom

  • Site GB44007

    RECRUITING

    London, United Kingdom

  • Site GB44008

    RECRUITING

    Liverpool, United Kingdom

  • Site GR30001

    RECRUITING

    Thessaloniki, Greece

  • Site GR30002

    RECRUITING

    Athens, Greece

  • Site HR38501

    RECRUITING

    Zagreb, Croatia

  • Site HR38503

    RECRUITING

    Zagreb, Croatia

  • Site IE35301

    RECRUITING

    Dublin, Ireland

  • Site IT39003

    RECRUITING

    Milan, Italy

  • Site IT39004

    RECRUITING

    Padova, Italy

  • Site LB96101

    RECRUITING

    El Achrafiyé, Lebanon

  • Site LT37001

    RECRUITING

    Vilnius, Lithuania

  • Site NL31002

    RECRUITING

    Rotterdam, Netherlands

  • Site NO47002

    RECRUITING

    Oslo, Norway

  • Site PL48002

    RECRUITING

    Warsaw, Poland

  • Site PL48003

    RECRUITING

    Krakow, Poland

  • Site RO40001

    RECRUITING

    Timișoara, 30011, Romania

  • Site RO40002

    RECRUITING

    Clug Napoca, 400370, Romania

  • Site SA96601

    RECRUITING

    Riyadh, Saudi Arabia

  • Site SA96602

    RECRUITING

    Dammam, Saudi Arabia

  • Site SE46002

    RECRUITING

    Mölnlycke, Sweden

  • Site SE46003

    RECRUITING

    Mölnlycke, Sweden

  • Site SK42101

    RECRUITING

    Bratislava, Slovakia

  • Site SP34001

    RECRUITING

    Madrid, 28041, Spain

  • Site TR90001

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Site TR90002

    RECRUITING

    Manisa, Turkey (Türkiye)

  • Site TR90003

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Site TR90005

    RECRUITING

    İzmit, Turkey (Türkiye)

  • Site TR90006

    RECRUITING

    Kayseri, Turkey (Türkiye)

  • Site TR90007

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Site TR90008

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Site TR90010

    RECRUITING

    Ankara, Turkey (Türkiye)

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