EUCTR2017-004605-41-BE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
适应症
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 IgAN.
- •3. Urine protein excretion value =1.0 g/day at screening.
- •4. eGFR value of =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. 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 open-label sparsentan). One additional barrier method must also be used during 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.
- •Criteria for the Sparsentan + SGLT2 Inhibitor Sub-study
- •Inclusion Criteria for the Sparsentan + SGLT2 Inhibitor Sub-study:
- •Based on assessments at a regularly scheduled open-label extension visit, a patient must meet all of the following criteria to be eligible for the Sub-study:
- •1. The patient is participating in the open-label extension and is willing and able to provide signed informed consent for participation in the open-label extension period Sub-study.
- •2. The patient has a urine protein excretion value of =0.3 g/day.
- •3. The patient has an eGFR of =25 mL/min/1.73m2.
- •4. The patient is on a stable dose of sparsentan for =8 weeks in the open-label extension period that is the maximum tolerated dose.
- •5. The patient has =12 weeks of the study remaining.
- •6. The patient fulfils local requirements, recommendations and does not have contraindications for on-label prescription of dapagliflozin.
- •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
- •Exclusion 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. 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 open-label 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 of =20 mL/min/1.73 m2 at Week 110.
- •5. The patient has a potassium value of >5.5 mEq/L (5.5 mmol/L).
- •6. The female patient is pregnant or is breastfeeding.
- •Exclusion Criteria for the Sparsentan + SGLT2 inhibitor Sub-study:
- •Based on assessments at an open-label extension visit, a patient who meets any of the following criteria will be excluded from participation in the open-label extension period Sub-study:
- •1. The patient has progressed to ESRD requiring RRT.
- •2. The patient has initiated or changed dose of a systemic immunosuppressive medication (including systemic steroids) within 12 weeks.
- •3. The patient has been taking an SGLT2 inhibitor within 12 weeks.
- •4. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the Sub-study.
研究者
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