A Study of Luspatercept in People With Anemia

Официальное название

A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease

Обзор

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.

Вмешательства

• Препарат Luspatercept
  Luspatercept subcutaneous injection once every 3 weeks

Первичные конечные точки

• Hemoglobin (HB) improvement [Срок оценки: within 12 weeks]

Вторичные конечные точки (1)

• Hemoglobin (HB) improvement [Срок оценки: within week 28]

Критерии участия

Критерии включения

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 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
• Memorial Sloan Kettering at Suffolk - Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center — New York
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT07725497 · 26-194

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗