AnemiaPhase 2NCT07725497
A Study of Luspatercept in People With Anemia
A Phase 2 study testing Luspatercept in people with Anemia and Chronic Kidney Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Luspatercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 20 Jul 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jeffrey Zwicker, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Jodi Mones, MD, 646-608-3722
- Recruiting
Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Jodi Mones, MD, 646-608-3722
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Jodi Mones, MD, 646-608-3722
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Jodi Mones, MD, 646-608-3722
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Jodi Mones, MD, 646-608-3722
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jodi Mones, MD, 646-608-3722
Jeffrey Zwicker, MD, 646-608-3723
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Jodi Mones, MD, 646-608-3722
About this study
Official title: A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease
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
- Being tested
- Luspatercept
- Keywords
- Luspatercept, 26-194
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LuspaterceptDrug
Luspatercept subcutaneous injection once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Luspatercept | Experimental | Luspatercept subcutaneous injection once every 3 weeks Receives: Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (HB) improvement
of at least 1.0 g/dl
Measured: within 12 weeks
Secondary outcomes (1)
Hemoglobin (HB) improvement
by at least 1.5 g/dL
Measured: within week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start20 Jul 2026
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725497
- Sponsor's protocol ID
- 26-194
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07725497
- Acronym / sponsor ID
- 26-194
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- Luspatercept, 26-194
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luspatercept | Experimental | Drug: LuspaterceptLuspatercept subcutaneous injection once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuspaterceptLuspatercept subcutaneous injection once every 3 weeks | Drug | Luspatercept |
Primary outcome
Hemoglobin (HB) improvement
Time frame: within 12 weeks
of at least 1.0 g/dl
1 secondary outcome
Hemoglobin (HB) improvement
Time frame: within week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Zwicker, MD contact
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luspatercept in people with Anemia and Chronic Kidney Disease, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodi Mones, MD (646-608-3722, monesj@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (HB) improvement (time frame: within 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.