ClinicalTrials.gg
RecruitingNCT07725497Updated Oct 13, 2026

A Study of Luspatercept in People With Anemia

A Phase 2 interventional study of Luspatercept in Anemia and Chronic Kidney Disease, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anemia
  • Chronic Kidney Disease

Keywords

  • Luspatercept
  • 26-194
03

In context

Anemia

1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.

This study's planned enrollment of 30 is below the median of 117 across 1,336 interventional studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Documentation of Anemia due to CKD

  • Patients must have a ≤ 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 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 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
  • Performance Status of ≤ 2
  • Not Pregnant and Not Nursing Required Organ Function
  • Adequate hematologic function defined as follows:
  • (ANC) ≥ 1,000 cells/mm3
  • ≥ 75,000 cells/mm3
  • Adequate hepatic function defined as follows:
  • Total ≤ 1.5 x institutional (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)
  • and ALT ≤3 x institutional ULN
  • Comorbid Conditions
  • Patients with a history of a solid organ can be included if they have been in remission for at least 12 months.

Exclusion criteria

Exclusion Criteria:

  • Evidence of recent (within previous 4 weeks) bleeding including gastrointestinal to explain anemia.
  • Evidence of hemolysis (LDH ≥ 2 x and haptoglobin below lower limit of normal)
  • Known diagnosis of myelodysplastic syndrome or any known hematologic [not including monoclonal of undetermined significance (MGUS) or monoclonal b-cell lymphocytosis (MBL)] not in remission
  • \< 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
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Luspatercept

    Luspatercept subcutaneous injection once every 3 weeks

    Drug: Luspatercept

Interventions

  • Luspatercept subcutaneous injection once every 3 weeks

06

What researchers measure

Primary outcomes

  1. Hemoglobin (HB) improvement

    of at least 1.0 g/dl

    Time frame: within 12 weeks

Secondary outcomes

  1. Hemoglobin (HB) improvement

    by at least 1.5 g/dL

    Time frame: within week 28

07

Study locations

7 of 7 sites recruiting
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey 07920, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey 07748, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey 07645, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
  • Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)
    Commack, New York 11725, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York 10604, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
    • Jeffrey Zwicker, MD · Contact646-608-3723
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York 11553, United States
    Recruiting
    • Jodi Mones, MD · Contact646-608-3722
08

References and documents

Individual participant data

Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07725497
Responsible party
Sponsor
First posted
Jul 24, 2026
Start date
Jul 20, 2026
Primary completion
Jul 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
Oct 13, 2026

Study contacts

Jodi Mones, MD
Contact
monesj@mskcc.org
646-608-3722
Jeffrey Zwicker, MD
Contact
646-608-3723

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Luspatercept

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