Anemia study: Luspatercept
Official title A Study of Luspatercept in People With Anemia
ClinicalTrials.gov ID: NCT07725497
What this study is testing
What is Luspatercept?
This is an investigational injectable medicine being studied to see if it can help improve hemoglobin levels in people with anemia caused by chronic kidney disease. It is designed to help the body make more red blood cells by changing how certain proteins signal the bone marrow.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if luspatercept can improve hemoglobin levels. It also checks if the treatment is safe and has few side effects.
- Who it's for
- People with anemia caused by chronic kidney disease.
- What's involved
- Participants will receive luspatercept and undergo tests to monitor their blood levels and any side effects.
- Time commitment
- The source text does not specify the duration or visit schedule.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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.
- Age ≥ 18
- ECOG Performance Status of ≤ 2
- Not Pregnant and Not Nursing Required Organ Function
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- Platelets ≥ 75,000 cells/mm3
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.