A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis (FSGS)

Travere Therapeutics, Inc.0 个研究点目标入组 300 人开始时间: 2018年6月25日最近更新: 2024年7月8日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Travere Therapeutics, Inc.
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

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. The patient or parent/legal guardian (as appropriate) is willing and
•able to provide signed informed consent/assent
•2. Biopsy-proven primary FSGS or documentation of a genetic mutation in a podocyte protein associated with FSGS. The biopsy may have been
•performed at any time in the past. The patient will be enrolled based on
•light microscopy diagnosis of FSGS and supportive findings on either
•electron microscopy (EM) or immunofluorescence (IF) analysis
•(preferably both). In exceptional cases, the patient may be enrolled
•based on light microscopy diagnosis of FSGS lesion(s) in the absence of
•EM or IF analysis, provided the history and/or the course of the disease
•are indicative of primary FSGS and the case has been reviewed by the
•Medical Monitor and Investigator.
•3. Male or female aged 18 to 75 years, inclusive weighting at least 20kgat screening (Note: patients under 18 may be recruited only in United States and United Kingdom).
•4. UP/C =1.5 g/g (170 mg/mmol) at screening.
•5. eGFR =30 mL/min/1.73 m2 at screening.
•6. Mean seated blood pressure =100/60 mmHg and =160/100 mmHg.
•7. WOCBP agree to the use of contraception and pregnancy testing as described in the protocol.
•Inclusion Criteria for the Open-Label Extension:
•Based on assessments at the Week 108 visit, a patient will meet all of the following criteria to be eligible for the open-label extension.
•1.The patient completed participation in the double-blind period, including the Week 112 visit.
•2.The patient or parent/legal guardian (as appropriate) is willing and able to provide signed informed consent for participation in the open label extension.
•3.The patient received blinded study medication throughout the duration of the double blind period (ie, did not permanently discontinue study medication).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

排除标准

•1. FSGS secondary to another condition.
•2. Positive findings on serological tests of primary or secondary glomerular injury.
•3. History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose >180 mg/dL (10.0 mmol/L) at screening.
•4. Any organ transplantation, with the exception of corneal transplants.
•5. Treatment with any of the prohibited concomitant medications.
•6. Treatment with rituximab, cyclophosphamide, or abatacept within =3 months prior to screening. If a patient is taking other chronic immunosuppressive medications, the dosage must be stable for =1 month prior to randomization.
•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. Hemodynamically significant valvular disease.
•10. Jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomatic cholelithiasis), or transaminase levels >2 times the upper limit of the normal range at screening.
•11. Positive at screening for the human immunodeficiency virus (HIV) or markers indicating acute or chronic hepatitis B (HBV) infection or hepatitis C virus (HCV) infection.
•12. History of malignancy other than adequately treated basal cell or squamous cell skin cancer or cervical carcinoma within the past 2 years.
•13. A screening hematocrit value <27% (0.27 L/L) or hemoglobin value <9 g/dL (90g/L).
•14. A screening potassium value of >5.5 mEq/L (5.5 mmol/L)
•15. Body mass index (BMI) >40 and there is a casual relationship to the FSGS lesion.
•16. History of alcohol or illicit drug use, or excessive alcohol intake (>21 units per week within 2 years of screening)
•17. History of serious side effect or allergic response to any Ang II antagonist or ERA or hypersensitivity to any of the excipients.
•18. Female patients is pregnant, breastfeeding, or planning to conceive during the study.
•19. Participation in a study of another investigational product within 28 days prior to screening.
•20. Prior exposure to sparsentan.
•21. Unable to adhere to the requirements of the study, including swallowing the study medication capsules whole.
•Exclusion Criteria for the Open-Label Extension:
•Based on assessments at the Week 108 and Week 112 visits, a patient
•who meets any of the following criteria will be excluded from the open
•1.The patient has progressed to ESRD requiring RRT.
•2.The patient developed criteria for discontinuation as defined in Section
•6.4.2 or Section 6.5 between Week 108 and Week 112.
•3.The patient was unable to initiate, or developed contraindications to,
•treatment with RAAS inhibitors between Week 108 and Week 112.
•4.The patient has an eGFR =20 mL/min/1.73 m2 at Week 108. NOTE: If,
•in the Investigator's opinion, the eGFR value at Week 108 is deemed
•unlikely to be representative of the patient's true status, the
•Investigator may repeat the eGFR measurement prior to Week 112
•through the central laboratory to assess patient eligibility. Patients with
•an eGFR <30 mL/min/1.73 m2 will require close monitoring of eGFR and
•serum potassium throughout the open-label extension.
•5. The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.

研究者

发起方

Travere Therapeutics, Inc.

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