A Study of Luspatercept in People With Anemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Luspatercept
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov