Can a drug that boosts red blood cells help anemia in kidney disease?
NCT ID NCT07725497
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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