EUCTR2017-004605-41-IT进行中（未招募）1 期
A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy - Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)
RETROPHIN, INC0 个研究点目标入组 280 人开始时间: 2021年1月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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. Male or female, aged =18 years.
- •2. Biopsy-proven primary IgAN.
- •3. Urine total protein value =1.0 g/day at screening.
- •4. eGFR =30 mL/min/1.73 m2 at screening.
- •5. The patient has been on a stable dose of ACEI and/or ARB therapy for
- •at least 12 weeks prior to screening.
- •6. At screening, systolic blood pressure =150 mmHg and diastolic blood
- •pressure =100 mmHg.
- •7. The patient must agree to the use of two forms of contraception.
- •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 range 260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. IgAN secondary to another condition.
- •2. Cellular glomerular crescents present in >25% of glomeruli on renal
- •biopsy within 6 months prior to screening.
- •3. History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose
- •>180 mg/dL at screening.
- •4. Any organ transplantation, with the exception of corneal transplants.
- •5. Treatment with any of the prohibited concomitant medications.
- •6. Treatment with any systemic immunosuppressive medications
- •(including corticosteroids) for >2 weeks within 3 months prior to
- •7. Documented history of heart failure and/or previous hospitalization
- •for heart failure or unexplained dyspnea, orthopnea, paroxysmal
- •nocturnal dyspnea, ascites, and/or peripheral edema.
- •8. Clinically significant cerebrovascular disease and/or coronary artery
- •9. Jaundice, hepatitis, or known hepatobiliary disease (including
- •asymptomatic cholelithiasis), or transaminase levels >2 times the upper
- •limit of the normal range at screening.
- •10. History of malignancy other than adequately treated basal cell or
- •squamous cell skin cancer or cervical carcinoma within the past 2 years.
- •11. A screening hematocrit value <27% or hemoglobin value <9 g/dL.
- •12. A screening potassium value of >5.5 mEq/L.
- •13. Female patient is pregnant, breastfeeding or planning to conceive
- •during the study.
- •14. Male patient plans to father a child during the course of the study.
- •15. Participation in a study of another investigational product within 28
- •days prior to screening.
研究者
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