Phase
Condition
Glomerulonephritis
Treatment
Sparsentan
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged ≥18 years at the time of signing the informed consent.
Biopsy-proven IgAN. The biopsy may have been performed at any time in the past.
UA/C ≥0.3 g/g at screening
An eGFR value of ≥25 mL/min/1.73m^2 at screening.
On a stable dose of an SGLT2 inhibitor for at least 12 weeks prior to screening.
On a stable dose of ACEI and/or ARB therapy for at least 12 weeks prior to screeningthat is:
The participant's maximum tolerated dose (MTD), and
at least one half of the maximum labeled dose (MLD)
Systolic BP must be ≤160 mmHg, and diastolic BP must be ≤110 mmHg at screening.
For participants receiving chronic low dose systemic corticosteroids (defined as ≤10mg/day prednisone or equivalent), or an enteric formulation of budesonide and/or amineralocorticoid receptor antagonist (MRA), the dosage must be stable for ≥12 weeksprior to screening.
Exclusion
Exclusion Criteria:
IgAN secondary to another condition or immunoglobulin A (IgA) vasculitis.
Undergone any organ transplant, with the exception of corneal transplants.
Documented history of heart failure.
Taking high dose (defined as >10 mg/day prednisone) or other any systemicimmunosuppressive medications within 12 weeks of prior to screening.
Has clinically significant cerebrovascular disease (transient ischemic attack orstroke) and/or coronary artery disease (hospitalization for myocardial infarctionunstable angina, new onset of angina with positive functional tests, coronaryangiogram revealing stenosis, or a coronary revascularization procedure) within 3months prior to screening.
Has jaundice, hepatitis, or known hepatobiliary disease (excluding asymptomaticcholelithiasis), or ALT and/or AST >2 times the ULN range at screening.
Has a history of malignancy other than adequately treated basal cell or squamouscell skin cancer or cervical carcinoma within the past 2 years.
Has a history of serious side effect or allergic response to any AngII antagonist,ERA or sparsentan, or has a hypersensitivity to any of the excipients in the studyintervention.
Requires any of the prohibited concomitant medications.
Treatment with sparsentan within 12 weeks prior to screening
Has participated in a study of another investigational product within 28 days priorto screening or plans to participate in such a study during the course of thisstudy.
Has a screening hematocrit value <27% (0.27 Volume/Volume) or hemoglobin value <9g/dL (90 g/L).
Has a screening potassium value of >5.5 mEq/L (5.5 mmol/L).
Is pregnant, plans to become pregnant during the course of the study, or isbreastfeeding.
The participant, in the opinion of the Investigator, is unable to adhere to therequirements of the study, including the ability to swallow the study interventioncapsules whole.
Study Design
Study Description
Connect with a study center
Travere Investigational Site
Hong Kong,
Hong KongSite Not Available
Travere Investigational Site
Hong Kong 1819729,
Hong KongSite Not Available
Travere Investigational Site
Kowloon,
Hong KongSite Not Available
Travere Investigational Site
Kowloon 1819609,
Hong KongSite Not Available
Travere Investigational Site
Shatin,
Hong KongSite Not Available
Travere Investigational Site
Shatin 1818920,
Hong KongSite Not Available
Travere Investigational Site
Sheung Wan,
Hong KongSite Not Available
Travere Investigational Site
Sheung Wan 1818833,
Hong KongSite Not Available
Travere Investigational Site
Tsuen Wan,
Hong KongSite Not Available
Travere Investigational Site
Tsuen Wan 1818209,
Hong KongSite Not Available
Travere Investigational Site
Birmingham, Alabama 35233
United StatesSite Not Available
Travere Investigational Site
Birmingham 4049979, Alabama 4829764 35233
United StatesSite Not Available
Travere Investigational Site
Chula Vista, California 91910
United StatesSite Not Available
Travere Investigational Site
Garden Grove, California 92844
United StatesSite Not Available
Travere Investigational Site
Glendale, California 91206
United StatesSite Not Available
Travere Investigational Site
Chula Vista 5336899, California 5332921 91910
United StatesSite Not Available
Travere Investigational Site
Garden Grove 5351515, California 5332921 92844
United StatesSite Not Available
Travere Investigational Site
Glendale 5352423, California 5332921 91206
United StatesSite Not Available
Travere Investigational Site
Denver, Colorado 80230
United StatesSite Not Available
Travere Investigational Site
Denver 5419384, Colorado 5417618 80230
United StatesSite Not Available
Travere Investigational Site
Boise, Idaho 83706
United StatesSite Not Available
Travere Investigational Site
Chubbuck, Idaho 83202
United StatesSite Not Available
Travere Investigational Site
Idaho Falls, Idaho 83404
United StatesSite Not Available
Travere Investigational Site
Nampa, Idaho 83687
United StatesSite Not Available
Travere Investigational Site
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Travere Investigational Site
Chubbuck 5588842, Idaho 5596512 83202
United StatesSite Not Available
Travere Investigational Site
Idaho Falls 5596475, Idaho 5596512 83404
United StatesSite Not Available
Travere Investigational Site
Chicago, Illinois 60611
United StatesSite Not Available
Travere Investigational Site
Evergreen Park, Illinois 60805
United StatesSite Not Available
Travere Investigational Site
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Travere Investigational Site
Evergreen Park 4891431, Illinois 4896861 60805
United StatesSite Not Available
Travere Investigational Site
Fort Wayne, Indiana 46804
United StatesSite Not Available
Travere Investigational Site
Fort Wayne 4920423, Indiana 4921868 46804
United StatesSite Not Available
Travere Investigational Site
Kansas City, Kansas 66160
United StatesSite Not Available
Travere Investigational Site
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Travere Investigational Site
Louisville, Kentucky 40205
United StatesSite Not Available
Travere Investigational Site
Louisville 4299276, Kentucky 6254925 40205
United StatesSite Not Available
Travere Investigational Site
Shreveport, Louisiana 71101
United StatesSite Not Available
Travere Investigational Site
Shreveport 4341513, Louisiana 4331987 71101
United StatesSite Not Available
Travere Investigational Site
Albuquerque, New Mexico 87109
United StatesSite Not Available
Travere Investigational Site
Albuquerque 5454711, New Mexico 5481136 87109
United StatesSite Not Available
Travere Investigation SIte
Clifton Park, New York 12065
United StatesSite Not Available
Travere Investigational Site
Fresh Meadows, New York 11365
United StatesSite Not Available
Travere Investigational Site
New York, New York 10013
United StatesSite Not Available
Travere Investigation Site
Clifton Park 5112961, New York 5128638 12065
United StatesSite Not Available
Travere Investigational Site
Fresh Meadows 5118005, New York 5128638 11365
United StatesSite Not Available
Travere Investigational Site
New York 5128581, New York 5128638 10013
United StatesSite Not Available
Travere Investigational Site
Jacksonville, North Carolina 28546
United StatesSite Not Available
Travere Investigational Site
New Bern, North Carolina 28562
United StatesSite Not Available
Travere Investigational Site
Jacksonville 4473083, North Carolina 4482348 28546
United StatesSite Not Available
Travere Investigational Site
New Bern 4481682, North Carolina 4482348 28562
United StatesSite Not Available
Travere Investigational Site
Columbus, Ohio 43210
United StatesSite Not Available
Travere Investigational Site
Columbus 4509177, Ohio 5165418 43210
United StatesSite Not Available
Travere Investigational Site
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Travere Investigational Site
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesSite Not Available
Travere Investigational Site
Columbia, South Carolina 29203
United StatesSite Not Available
Travere Investigational Site
Columbia 4575352, South Carolina 4597040 29203
United StatesSite Not Available
Travere Investigational Site
Dallas, Texas 75230
United StatesSite Not Available
Travere Investigational Site
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available

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