A Study of Luspatercept in People With Anemia

NCT07725497 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 26-194
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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

Keywords

Luspatercept; 26-194

Outcome Measures

Primary Outcomes (1)

• Hemoglobin (HB) improvement

  of at least 1.0 g/dl

  within 12 weeks

Secondary Outcomes (1)

• Hemoglobin (HB) improvement

  within week 28

Study Arms (1)

Luspatercept

EXPERIMENTAL

Luspatercept subcutaneous injection once every 3 weeks

Drug: Luspatercept

Interventions

Luspatercept DRUG

Luspatercept subcutaneous injection once every 3 weeks

Luspatercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

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

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jodi Mones, MD

CONTACT

646-608-3722; monesj@mskcc.org

Jeffrey Zwicker, MD

CONTACT

646-608-3723

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

US (7)