Can a drug that boosts red blood cells help anemia in kidney disease?

NCT ID NCT07725497

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This phase 2 trial is testing whether luspatercept, a drug that stimulates red blood cell production, can raise hemoglobin levels in people with anemia caused by chronic kidney disease. About 30 participants will receive injections every three weeks. The study aims to see if the treatment is effective and safe, potentially offering a new way to manage this common complication.

What this could mean

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

Active substance
luspatercept
What this could lead to
If it works, this could offer a new treatment option for anemia in chronic kidney disease, potentially reducing the need for blood transfusions.
What could go wrong
This is an early-phase trial with only 30 participants, so results may not apply broadly. Side effects are possible, and the drug may not improve hemoglobin as hoped.

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.

Participants

About 30 people

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

Started

Jul 2026

Expected to finish

Jul 2029

An estimate. End dates often move.

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: Documentation of Anemia due to CKD * Patients must have a Hb ≤ 9.5 g/dL on two separate occasions within 4 weeks prior to enrollment. * Do not anticipate red cell transfusion within the following 4 weeks and no history of red cell transfusion in three weeks prior to enrollment. * Ferritin ≥100 ng/mL and iron transferrin saturation (TSAT) ≥ 20%. * Serum folate \> 4 ng/mL * Serum vitamin B12 \> 250 pg/mL * Patients may have received iron, B12 and folic acid repletion if initiated \> 6 weeks prior to enrollment. Patients who are already on iron, B12 and folic acid repletion can continue throughout the trial. * TSH, T4 within institutional normal limits. Documentation of Chronic Kidney Disease * Chronic kidney disease defined as a GFR between 30-60 mL/min/1.73m2 for ≥ 3 months calculated by the 2021 CKD-EPI creatinine equation for eGFR, the 2021 CKD-EPI creatinine-cystatin C equation, or creatinine clearance measured by a 24-hour urine collection. Prior Treatment with Erythrocyte Stimulating Agents (ESA) * Eligible patients will not have had recent (within past 3 weeks) erythrocyte stimulating agents (ESA) prior to enrollment unless they are hyporesponsive to ESA therapy. * Patients are eligible if they are either hyporesponsive to ESA therapy or unwilling to accept ESAs. defined by the Kidney Disease Outcomes Quality Initiative (KDOQI) as the inability to achieve/maintain a desired hemoglobin (herein defined as a hemoglobin of \> 9.0 g/dL) using a maximum dose of erythropoietin (450 units/kg/week IV or 300 units/kg/week SQ or the darbepoetin equivalent using the conversion of 45,000 units/week of epoetin = 100 mcg/week of darbepoetin). * Age ≥ 18 * ECOG Performance Status of ≤ 2 * Not Pregnant and Not Nursing Required Organ Function * Adequate hematologic function defined as follows: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 * Platelets ≥ 75,000 cells/mm3 * Adequate hepatic function defined as follows: * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled) * AST and ALT ≤3 x institutional ULN * Comorbid Conditions * Patients with a history of a solid organ malignancy can be included if they have been in remission for at least 12 months. Exclusion Criteria: * Evidence of recent (within previous 4 weeks) bleeding including gastrointestinal to explain anemia. * Evidence of hemolysis (LDH ≥ 2 x ULN and haptoglobin below lower limit of normal) * Known diagnosis of myelodysplastic syndrome or any known hematologic malignancy \[not including monoclonal of undetermined significance (MGUS) or monoclonal b-cell lymphocytosis (MBL)\] not in remission * GFR \< 30 mL/min/1.73m2 or on dialysis (no available data for luspatercept on HD) * Acute kidney injury ( ≤ 3 months) * Uncontrolled hypertension: repeated elevations of SBP ≥ 150 mmHg and/or DBP ≥ 100 mmHg despite adequate treatment * Known hemoglobinopathy. * Known inherited or acquired thrombophilia. * History of venous thromboembolism within past 2 years * Cerebral vascular accident within past 2 years * Recent (within 2 years) myocardial infarction * Allergy to luspatercept components

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    7 sites. 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

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)

    RECRUITING

    Commack, New York, 11725, United States

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