[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725497":3,"trial-entities:NCT07725497":164,"trial-summary:NCT07725497":167},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":45,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":83,"locations":86,"central_contacts":157,"overall_officials":161,"references":162,"see_also_links":163},"NCT07725497","26-194","A Study of Luspatercept in People With Anemia","A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease","RECRUITING","2029-07","2026-07","2026-07-24","2026-07-20","Memorial Sloan Kettering Cancer Center","OTHER",false,"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.",null,[19,20],"Anemia","Chronic Kidney Disease",[22,5],"Luspatercept","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},30,"ESTIMATED",[31],{"type":32,"name":22,"description":33,"armGroupLabels":34},"DRUG","Luspatercept subcutaneous injection once every 3 weeks",[22],[36],{"measure":37,"description":38,"timeFrame":39},"Hemoglobin (HB) improvement","of at least 1.0 g\u002Fdl","within 12 weeks",[41],{"measure":37,"description":42,"timeFrame":43},"by at least 1.5 g\u002FdL","within week 28","ALL","18 Years",{"inclusion":47,"exclusion":69,"raw_text":82},[48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68],"Patients must have a Hb ≤ 9.5 g\u002FdL 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\u002FmL and iron transferrin saturation (TSAT) ≥ 20%.","Serum folate \\> 4 ng\u002FmL","Serum vitamin B12 \\> 250 pg\u002FmL","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\u002Fmin\u002F1.73m2 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.","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\u002Fmaintain a desired hemoglobin (herein defined as a hemoglobin of \\> 9.0 g\u002FdL) using a maximum dose of erythropoietin (450 units\u002Fkg\u002Fweek IV or 300 units\u002Fkg\u002Fweek SQ or the darbepoetin equivalent using the conversion of 45,000 units\u002Fweek of epoetin = 100 mcg\u002Fweek 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\u002Fmm3","Platelets ≥ 75,000 cells\u002Fmm3","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.",[70,71,72,73,74,75,76,77,78,79,80,81],"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 \\\u003C 30 mL\u002Fmin\u002F1.73m2 or on dialysis (no available data for luspatercept on HD)","Acute kidney injury ( ≤ 3 months)","Uncontrolled hypertension: repeated elevations of SBP ≥ 150 mmHg and\u002For 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","Inclusion Criteria:\n\nDocumentation of Anemia due to CKD\n\n* Patients must have a Hb ≤ 9.5 g\u002FdL on two separate occasions within 4 weeks prior to enrollment.\n* Do not anticipate red cell transfusion within the following 4 weeks and no history of red cell transfusion in three weeks prior to enrollment.\n* Ferritin ≥100 ng\u002FmL and iron transferrin saturation (TSAT) ≥ 20%.\n* Serum folate \\> 4 ng\u002FmL\n* Serum vitamin B12 \\> 250 pg\u002FmL\n* 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.\n* TSH, T4 within institutional normal limits. Documentation of Chronic Kidney Disease\n* Chronic kidney disease defined as a GFR between 30-60 mL\u002Fmin\u002F1.73m2 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.\n\nPrior Treatment with Erythrocyte Stimulating Agents (ESA)\n\n* 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.\n* 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\u002Fmaintain a desired hemoglobin (herein defined as a hemoglobin of \\> 9.0 g\u002FdL) using a maximum dose of erythropoietin (450 units\u002Fkg\u002Fweek IV or 300 units\u002Fkg\u002Fweek SQ or the darbepoetin equivalent using the conversion of 45,000 units\u002Fweek of epoetin = 100 mcg\u002Fweek of darbepoetin).\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2\n* Not Pregnant and Not Nursing Required Organ Function\n* Adequate hematologic function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n* Platelets ≥ 75,000 cells\u002Fmm3\n* Adequate hepatic function defined as follows:\n* 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)\n* AST and ALT ≤3 x institutional ULN\n* Comorbid Conditions\n* Patients with a history of a solid organ malignancy can be included if they have been in remission for at least 12 months.\n\nExclusion Criteria:\n\n* Evidence of recent (within previous 4 weeks) bleeding including gastrointestinal to explain anemia.\n* Evidence of hemolysis (LDH ≥ 2 x ULN and haptoglobin below lower limit of normal)\n* 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\n* GFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 or on dialysis (no available data for luspatercept on HD)\n* Acute kidney injury ( ≤ 3 months)\n* Uncontrolled hypertension: repeated elevations of SBP ≥ 150 mmHg and\u002For DBP ≥ 100 mmHg despite adequate treatment\n* Known hemoglobinopathy.\n* Known inherited or acquired thrombophilia.\n* History of venous thromboembolism within past 2 years\n* Cerebral vascular accident within past 2 years\n* Recent (within 2 years) myocardial infarction\n* Allergy to luspatercept components",[84,85],"ADULT","OLDER_ADULT",[87,101,110,119,129,138,148],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":98},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[94],{"name":95,"role":96,"phone":97},"Jodi Mones, MD","CONTACT","646-608-3722",{"lat":99,"lon":100},40.70621,-74.54932,{"facility":102,"status":8,"city":103,"state":90,"zip":104,"country":92,"contacts":105,"geoPoint":107},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[106],{"name":95,"role":96,"phone":97},{"lat":108,"lon":109},40.39428,-74.11709,{"facility":111,"status":8,"city":112,"state":90,"zip":113,"country":92,"contacts":114,"geoPoint":116},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[115],{"name":95,"role":96,"phone":97},{"lat":117,"lon":118},41.04676,-74.02292,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":92,"contacts":124,"geoPoint":126},"Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",[125],{"name":95,"role":96,"phone":97},{"lat":127,"lon":128},40.84288,-73.29289,{"facility":130,"status":8,"city":131,"state":122,"zip":132,"country":92,"contacts":133,"geoPoint":135},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[134],{"name":95,"role":96,"phone":97},{"lat":136,"lon":137},40.96899,-73.71263,{"facility":13,"status":8,"city":122,"state":122,"zip":139,"country":92,"contacts":140,"geoPoint":145},"10065",[141,142],{"name":95,"role":96,"phone":97},{"name":143,"role":96,"phone":144},"Jeffrey Zwicker, MD","646-608-3723",{"lat":146,"lon":147},40.71427,-74.00597,{"facility":149,"status":8,"city":150,"state":122,"zip":151,"country":92,"contacts":152,"geoPoint":154},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",[153],{"name":95,"role":96,"phone":97},{"lat":155,"lon":156},40.70038,-73.59291,[158,160],{"name":95,"role":96,"phone":97,"email":159},"monesj@mskcc.org",{"name":143,"role":96,"phone":144},[],[],[],{"nct_id":4,"conditions":165,"biomarkers":166},[19,20],[],{"nct_id":4,"found":168,"summary":169,"prompt_version":179},true,{"design":170,"status":171,"heading":172,"summary":173,"follow_up":174,"word_count":175,"commitments":176,"compensation":177,"drugs_mentioned":178},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.","completed","A Study of Luspatercept for Anemia in Chronic Kidney Disease","This study is testing a medication called luspatercept to see if it can improve hemoglobin (a protein in red blood cells that carries oxygen) levels in people who have anemia (low red blood cell count) due to chronic kidney disease (CKD). Researchers also want to see if luspatercept is safe and causes few or mild side effects. You might be able to join if you are an adult with anemia from CKD, have specific hemoglobin levels (9.5 g\u002FdL or less), and meet certain iron levels (ferritin of 100 ng\u002FmL or more and iron transferrin saturation of 20% or more). The main goal is to see if your hemoglobin improves within 12 weeks. The current status of this study is unclear, but it plans to enroll 30 people.","Hemoglobin improvement will be measured within 12 weeks.",127,"You would receive luspatercept as an injection under the skin once every three weeks.","Not stated in the trial record.",[22],"v2"]