Recruiting

Phase 2

LuspaterceptA Study of Luspatercept in People With Anemia

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07725497

Conditions

Anemia

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Luspatercept

Study Details

Brief summary:

The researchers are doing this study to test whether luspatercept works to improve hemoglobin levels in people with anemia caused by chronic kidney disease (CKD). The researchers will also test whether luspatercept is a safe treatment that causes few or mild side effects in participants.

Conditions

Anemia

Chronic Kidney Disease

Study ID

NCT07725497

Start date

Jul 20, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Luspatercept

Luspatercept subcutaneous injection once every 3 weeks

Interventions

Luspatercept

Luspatercept subcutaneous injection once every 3 weeks

Primary outcome measure

Hemoglobin (HB) improvement [ Time Frame: within 12 weeks ]

Central Contacts and Locations

Central contacts

Jodi Mones, MD

646-608-3722 monesj@mskcc.org

Jeffrey Zwicker, MD

646-608-3723

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jodi Mones, MD

646-608-3722

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jodi Mones, MD

646-608-3722

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jodi Mones, MD

646-608-3722

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

Recruiting

Commack, New York, United States, 11725

Contacts

Jodi Mones, MD

646-608-3722

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jodi Mones, MD

646-608-3722

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jodi Mones, MD

646-608-3722

Jeffrey Zwicker, MD

646-608-3723

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Jodi Mones, MD

646-608-3722

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

Luspatercept
26-194

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-24.