ACTRN12622000066785招募中3 期
A pivotal Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with focal segmental glomerulosclerosis (FSGS) who are receiving an angiotensin II receptor blocker (ARB)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 286
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •DOUBLE BLIND PERIOD
- •1. Patients must be 12 to 80 years old (adolescents will only be recruited in Argentina, Mexico, UK, US).
- •2. A diagnosis of primary FSGS, genetic FSGS, or FSGS of undetermined cause.
- •4. If taking corticosteroids, the dosage must be stable for greater than or equal to 4 weeks prior to Screening and during Stabilization.
- •5. If taking aldosterone inhibitors, mineralocorticoid receptor antagonists, direct renin inhibitors, or sodium-glucose co-transporter-2 (SGLT2) inhibitors, or endothelin receptor antagonists (ERAs, including dual antagonists), the dose and regimen must be stable for greater than or equal to 12 weeks prior to Screening and during Stabilization.
- •7. Estimated GFR
- •8. Seated blood pressure less than or equal to 160/100 mm Hg (mean of 3 values) (patients greater than or equal to 18 years of age) or between the 5th and 95th percentile for age, sex, and height 29 (patients <18 years of age) at Screening.
- •9. Body weight greater than or equal to 35 kg (all patients) AND a BMI less than or equal to 40 kg/m2 (patients greater than or equal to 18 years of age) or between the 5th and 98th percentile for age and sex (patients <18 years of age) at Screening.
- •10. A female patient is eligible to participate if she is not pregnant or planning to become pregnant during the study, not breastfeeding, and at least one of the following conditions applies:
- •b. Is of childbearing potential and beginning at menarche, agrees to use a highly effective method of contraception consistently during the treatment period.
- •method of contraception consistently during the treatment period
- •11. A male patient with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception
- •1. Patients who have completed participation in the double-blind period, including the Week 104 visit, and who may derive benefit from (continued) treatment with DMX-200, and/or continued follow-up
- •2. The patient received blinded Investigational Product throughout the duration of the double-blind period up to the Week 104 visit
- •3. The patient continues to meet the contraceptive requirements
排除标准
- •DOUBLE-BLIND PERIOD
- •1. Has FSGS secondary to another condition.
- •2. History of type 1 diabetes mellitus, or uncontrolled type 2 diabetes mellitus (defined as glycated hemoglobin [HbA1c] >8%)
- •3. History of lymphoma, leukemia, or any active malignancy within the past 2 years
- •4. Active clinically significant hepatobiliary disease.
- •5. Documented history of heart failure (New York Heart Association Class III/IV) or a major adverse cardiac event within 12 weeks prior to Screening.
- •6. Has a physical, medical, or psychological condition, that in the opinion of the Investigator, may interfere with the evaluation the study.
- •7. The patient has a history of alcohol or illicit drug use disorder within 1 year prior to Screening.
- •8. Had a prior organ transplant or stem cell transplant, with the exception of corneal transplant.
- •9. Positive screening assessment for viral hepatitis B surface antigen, or anti-hepatitis C virus antibody AND positive HCV RNA, or human immunodeficiency virus 1 and 2.
- •10. Serum potassium levels >5.5 mmol/L at Screening.
- •11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 × upper limit of normal (ULN) at Screening
- •12. Treatment with immunosuppressant biological drugs, calcineurin inhibitors, cyclophosphamide, azathioprine, or mycophenolate mofetil within 12 weeks prior to Screening.
- •13. History of serious side effects or allergic response to an angiotensin II antagonist or has a known sensitivity to any components in the Investigational Product.
- •14. Unable to swallow oral medication.
- •15. Prior participation in any Dimerix-sponsored DMX-200 clinical study.
- •16. Participation in a clinical study with an Investigational Product within 28 days or 5 half-lives (whichever is longer) prior to Screening or plans to participate in another study during the course of this study.
- •17. Are study site personnel directly affiliated with this study and their immediate families.
- •1. The patient has met the criteria for permanent IP discontinuation or study discontinuation.
- •2. Any safety concerns identified during the double-blind period which, in the Investigator's opinion, may interfere with the patient's continued participation during the OLE period.
研究者
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