EUCTR2017-004605-41-PL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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 380
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
- •Inclusion Criteria for Double-Blind Period:
- •1. Male or female, aged =18 years.
- •2. Biopsy-proven primary IgAN.
- •3. Urine protein excretion value =1.0 g/day at screening
- •4.eGFR value of= 30mL/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. Women of childbearing potential (WOCBP) must agree to the use of two forms of contraception
- •Inclusion Criteria for Open-Label Extension Period:
- •Based on assessments at the Week 110 and Week 114 visit, a patient must meet all of the following criteria to be eligible for the open-label extension period.
- •1. The patient completed participation in the double-blind period,including the Week 114 visit.
- •2. The patient is willing and able to provide signed informed consent for participation in the open-label extension period.
- •3. The patient did not permanently discontinue study medication during the double-blind period.
- •4. WOCBP, beginning at menarche, must agree to the use of 1 highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of study medication
- •until 90 days after the last dose of study medication (including openlabel sparsentan). One additional barrier method must also be useduring sexual activity, such as a diaphragm or diaphragm with
- •spermicide (preferred), or male partner's use of male condom or male
- •condom with spermicide (preferred), from the Week 114 visit until 90 days after the last dose of study medication.
- •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 340
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Exlusion Criteria for the Double-Blind Period:
- •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. The patient has a chronic kidney disease in addition to IgAN
- •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 screening.
- •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 disease
- •9. Jaundice, hepatitis, or known hepatobiliary disease (excluding 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% (0.27 Volume/Volume) or hemoglobin value <9 g/dL (90 g/L).
- •12. A screening potassium value of >5.5 mEq/L. (5.5 mmol/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.
- •Exclusion Criteria for the Open-Label Extension Period:
- •Based on assessments at the Week 110 and Week 114 visits, a patient
- •who meets any of the following criteria will be excluded from the openlabel extension period:
- •1. The patient has progressed to end-stage renal disease (ESRD)requiring renal replacement therapy (RRT).
- •2. The patient developed any criteria for discontinuation of study medication or discontinuation from the study, respectively, between Week 110 and Week 114.
- •3. The patient was unable to initiate, or developed contraindications to, treatment with RAAS inhibitors between Week 110 and Week 114.
- •4. The patient has an eGFR value =20 mL/min/1.73 m2 at Week 110.
- •5. The patient has a potassium value of >5.5 mEq/L (5.5mmol/L) 6. The female patient is pregnant or is breastfeeding.
研究者
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