EUCTR2012-003788-23-ES进行中（未招募）1 期
A Phase 2 Multicenter, Randomized, Open Label, Multiple Dose Study of Intravenous and Subcutaneous Administration of Sotatercept (ACE-011) in Subjects with End-Stage Kidney Disease on Hemodialysis Switched from Erythropoiesis Stimulating Agents with Staggered Dose Group Escalation in Part 1 Followed by a Parallel Group, Active Controlled Study of Selected Dose(s) and Regimen(s) in Part 2: to Evaluate the Pharmacokinetics, Safety, Tolerability, Efficacy, Dosing Regimen, and Pharmacodynamics of Sotatercept
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 285
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males or females ? 18 years of age at the time of signing informed consent document.
- •2.Clinically stable in the judgment of the investigator.
- •3.Subjects on at least 6 hours of hemodialysis per week, for at least 12 weeks before screening and during the study.
- •4.Subjects must be on a stable IV or SQ dose of ESA (excluding methoxy polyethylene glycol epoetin-beta) to maintain hemoglobin. A stable dose is defined as ? 50% change from the maximum prescribed weekly ESA dose ([max-min]/max ? 0.5) and no change in frequency during the last 6 weeks prior to randomization unless the dose is held for high hemoglobin. If ESA dose is held for high hemoglobin, subject must be restarted on a stable dose (defined as ? 50% change from prior dose). Maximum allowed ESA dose must be equivalent to epoetin ? 500 IU/kg/week, or darbepoetin ? 95 mcg/week.
- •5.A mean hemoglobin concentration ? 10 to ? 12 g/dL (? 100 to ? 120 g/L) obtained from three consecutive (each done on different days) predialysis hemoglobin concentrations, with the last hemoglobin concentration done within the 7 days prior to randomization (if local laboratory values are used, they should be obtained consistently from the same laboratory).
- •6.Subjects must have adequate iron status defined as one transferrin saturation ? 20% prior to randomization.
- •7.A Kt/V ? 1.2 or urea reduction ratio ? 65% at screening, (historical values within 1 month prior to screening are acceptable).
- •8.The subject has one PTH concentration ? 1000 pg/mL, one phosphorus concentration ? 7 mg/dL, one total albumin-corrected calcium concentration > 8.0 mg/dL to < 10.5 mg/dL , and one magnesium concentration ? 1.5 mEq/L prior to randomization.
- •9.A BMI value ? 18.5 kg/m2 at screening. Weight at screening will be collected postdialysis (dry weight) for BMI calculation.
- •10.Female subjects of childbearing potential participating in the study are to use highly effective methods of birth control during study participation. Females of childbearing potential must have a negative serum pregnancy test prior to randomization. In addition, subjects must be educated concerning measures to be used to prevent pregnancy and potential toxicities. (A female of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or who has not been postmenopausal for at least 24 consecutive months ie, who has had menses at some time in the preceding 24 months).
- •Some highly effective methods of birth control include:
- •?Oral contraceptives, intrauterine device, tubal ligation or vasectomized partner
- •?Two forms of barrier method birth control, e.g., a latex condom PLUS a diaphragm with spermicide OR a latex condom PLUS a contraceptive sponge with spermicide. If a non-latex condom is used, it cannot be made out of natural (animal) membrane
- •11.Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or non latex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while participating in the study.
- •12.Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- •13.Able to adhere to the study visit schedule and comply with all protocol requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age r
排除标准
- •1. Non renal causes of anemia due to active inflammatory disease such as systemic lupus erythematosus, active liver disease, hypersplenism, gastrointestinal bleeding, osteomyelitis, tuberculosis, lung abscess, etc.
- •2. Subjects on peritoneal dialysis.
- •3. Systemic hematological disease such as sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia.
- •4. High sensitivity C-reactive protein > 50 mg/L at screening.
- •5. Subject has alanine transaminase (ALT) or aspartate transaminase (AST) laboratory
- •values > 2 times the upper limit of normal (ULN) at screening.
- •6. Uncontrolled diabetes mellitus (HbA1c > 9) at screening.
- •7. Uncontrolled hypertension defined as mean of home systolic blood pressure > 160 mm Hg or mean of home diastolic blood pressure > 90 mm Hg calculated once during the screening period prior to randomization (A mean of 4 consecutive days of home systolic and diastolic blood pressure values taken during a 7-day window in the screening period prior to randomization, with a minimum of 6 values for calculating the mean are required - 3 taken from a single morning set of measurements, and 3 taken from a single evening set of measurements. Note: Both the mean systolic and diastolic home blood pressure eligibility must be met).
- •8. Subjects with heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher, (see Appendix E).
- •9. Compromised venous access for the purpose of hemodialysis or obtaining blood samples for the study.
- •10. Subjects taking high dose vitamin D or calcimimetic medications (such as cinacalcet ? 120 mg once daily; paricalcitol 0.24 mcg/kg three times weekly; doxercalciferol 6 mcg three times weekly) within 3 months prior to screening and during the course of the study.
- •11. Subjects taking drugs that affect bone turnover (see prohibited concomitant therapy Section 9.2) within 3 months prior to screening and during the course of the study.
- •12. ESKD due to malignancy.
- •13. History of malignancy (except excised and cured non-melanoma skin cancer, or cervical carcinoma in situ that was surgically ablated more than 1 year ago).
- •14. Active serious infection or history of a recurrent serious infection that is likely to recur during the study, with the last infection within 3 months prior to the screening visit (immunosuppressants and high dose corticosteroids are excluded eg, prednisone ? 10 mg per day or equivalent, see Section 9.2).
- •15. Subject has human immunodeficiency virus (HIV).
- •16. Major surgeries or surgeries (excludes vascular access surgery) requiring hospitalization within 28 days prior to randomization and/or expected during the course of the study (subjects must have, in the judgment of the investigator, completely recovered from any previous surgery prior to randomization).
- •17. Anticipated or scheduled living donor renal transplant during the course of the study.
- •18. Any RBC transfusions within 8 weeks prior to screening.
- •19. Life expectancy < 1 year.
- •20. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational product or to the specific iron products needed to normalize iron levels for subjects or to tetracycline (or appropriate substitute) for subjects who consent to bone biopsy.
- •21. Subjects who received treatment with another investigational drug or device within 28 days prior to randomization, or if the half-life of the previous product is known, with
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