Actively Recruiting
Phase 2 Trial of Luspatercept Injection for Adults with Anemia Due to Chronic Kidney Disease
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-07-24
30
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating luspatercept to see if it can improve hemoglobin levels in adults with anemia caused by chronic kidney disease CKD. This study also aims to assess the safety of luspatercept by monitoring side effects in participants. The trial is a phase 2 treatment study sponsored by Memorial Sloan Kettering Cancer Center. Participants will receive luspatercept as a subcutaneous injection once every three weeks. The study does not include a comparison group and focuses on how luspatercept affects hemoglobin levels over time, particularly within 12 weeks and up to week 28. The treatment period is designed to test the effects and safety of the drug in this patient group. During the study, participants will have their hemoglobin levels closely monitored to measure improvements. Researchers will also evaluate other health indicators to ensure safety and effectiveness. The study involves regular visits for treatment and assessment, with the overall participation lasting up to the study completion date in July 2029.
CONDITIONS
Brief Title
A Study of Luspatercept in People With Anemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed anemia due to chronic kidney disease with hemoglobin (Hb) ≤ 9.5 g/dL on two separate tests within 4 weeks prior to enrollment
- No red cell transfusion expected within 4 weeks and no transfusion within 3 weeks prior to enrollment
- Ferritin ≥ 100 ng/mL and iron transferrin saturation (TSAT) ≥ 20%
- Serum folate greater than 4 ng/mL
- Serum vitamin B12 greater than 250 pg/mL
- Patients may have received iron, B12, and folic acid supplements if started more than 6 weeks before enrollment; ongoing supplementation allowed
- Thyroid function (TSH, T4) within normal limits
- Chronic kidney disease defined as GFR between 30-60 mL/min/1.73m2 for at least 3 months
- No recent erythrocyte stimulating agents (ESA) within 3 weeks prior to enrollment unless hyporesponsive or unwilling to accept ESA therapy
- ECOG Performance Status of 2 or less
- Not pregnant and not nursing
- Adequate hematologic function: ANC ≥ 1,000 cells/mm3 and platelets ≥ 75,000 cells/mm3
- Adequate liver function with total bilirubin ≤ 1.5 times upper limit of normal (ULN), or up to 3 times ULN if Gilbert's disease; AST and ALT ≤ 3 times ULN
- Patients with history of solid organ malignancy in remission for at least 12 months
You will not qualify if you...
- Recent bleeding within 4 weeks, including gastrointestinal bleeding, causing anemia
- Evidence of hemolysis (LDH ≥ 2 times ULN and low haptoglobin)
- Diagnosis of myelodysplastic syndrome or hematologic malignancy not in remission (excluding MGUS or MBL)
- GFR less than 30 mL/min/1.73m2 or on dialysis
- Acute kidney injury within 3 months
- Uncontrolled high blood pressure despite treatment (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
- Known hemoglobin disorders
- Known inherited or acquired clotting disorders
- History of blood clots in veins or strokes within past 2 years
- Recent heart attack within past 2 years
- Allergy to any components of luspatercept
Research Team
J
Jodi Mones, MD
J
Jeffrey Zwicker, MD
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