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30 Participants NeededMy employer runs this trial

Luspatercept for Anemia in Chronic Kidney Disease

Recruiting at 6 trial locations
JM
JZ
Overseen ByJeffrey Zwicker, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: Iron, B12, Folic acid
Disqualifiers: Bleeding, Hemolysis, Hematologic malignancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with anemia caused by chronic kidney disease (CKD) who have moderately reduced kidney function, low hemoglobin levels, and stable iron, B12, and folate. Participants must not be pregnant or nursing and should not have severe heart issues, recent strokes or blood clots, active cancer (unless in remission), or need dialysis.

Inclusion Criteria

Serum folate > 4 ng/mL
Patients must have a Hb ≤ 9.5 g/dL on two separate occasions within 4 weeks prior to enrollment
Serum vitamin B12 > 250 pg/mL
See 14 more

Exclusion Criteria

My kidney function is severely reduced or I am on dialysis.
Known inherited or acquired thrombophilia
Evidence of hemolysis (LDH ≥ 2 x ULN and haptoglobin below lower limit of normal)
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive luspatercept subcutaneous injection once every 3 weeks

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Luspatercept

Trial Overview

The study tests luspatercept to see if it can safely raise hemoglobin levels in people with CKD-related anemia. All participants receive luspatercept; the focus is on its effectiveness and safety.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LuspaterceptExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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