Luspatercept for anemia due to chronic kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating luspatercept in adults with anemia from chronic kidney disease. Participants must meet specific criteria related to hemoglobin, iron status, and CKD duration, and they may continue certain iron and vitamin therapies. The study will monitor hemoglobin changes and track safety and side effects. Locations are limited to a few MSK facilities in New Jersey. The sponsor is Memorial Sloan Kettering Cancer Center, with Bristol-Myers Squibb as a collaborator.

Why it matters

Who can join: the full rules

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

Where it's running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (Limited Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Jodi Mones, MD
• Email: monesj@mskcc.org
• Phone: 646-608-3722

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.