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A Study of Luspatercept for Anemia in Chronic Kidney Disease

This study is testing a medication called luspatercept to see if it can improve hemoglobin (a protein in red blood cells that carries oxygen) levels in people who have anemia (low red blood cell count) due to chronic kidney disease (CKD). Researchers also want to see if luspatercept is safe and causes few or mild side effects. You might be able to join if you are an adult with anemia from CKD, have specific hemoglobin levels (9.5 g/dL or less), and meet certain iron levels (ferritin of 100 ng/mL or more and iron transferrin saturation of 20% or more). The main goal is to see if your hemoglobin improves within 12 weeks. The current status of this study is unclear, but it plans to enroll 30 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
You would receive luspatercept as an injection under the skin once every three weeks.
Compensation
Not stated in the trial record.
Follow-up
Hemoglobin improvement will be measured within 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07725497

A Study of Luspatercept in People With Anemia

Recruiting
PHASE2Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~30 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Luspatercept

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hemoglobin (HB) improvement
Measured over within 12 weeks

Conditions

Anemia
Chronic Kidney Disease

Explore related trials

AnemiaChronic Kidney Disease

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Who to contact

Jodi Mones, MD
[email protected]
646-608-3722
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

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

What this trial measures

  • Hemoglobin (HB) improvementwithin 12 weeks

    of at least 1.0 g/dl