Phase
Condition
Glomerulonephritis
Nephropathy
Kidney Disease
Treatment
TARPEYO®
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosed IgAN with biopsy verification
Female or male participants ≥18 years of age
Completion of 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
Access to retrospective local laboratory assessment data on UPCR and serumcreatinine. Available retrospective data should include at least 1 assessment timepoint within 3months prior to the first dose of TARPEYO® commercial treatment
Proteinuria at Screening based on 2 consecutive measurements (24-hour urinecollection) after informed consent, separated by at least 1 week and calculated bythe central laboratory. Both samples of the same parameter must show either of the following:
Proteinuria ≥0.5 g per day (≥500 mg per day) in 2 consecutive measurements, or
UPCR ≥0.3 g/gram in 2 consecutive measurements
On stable treatment with renin-angiotensin system (RAS) inhibitor therapy for atleast 8 weeks prior to the Baseline visit. A stable dose is defined as a dose within 25% of the dose at Baseline
If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, thetreatment should have been stable for at least 8 weeks prior to the Baseline visit.A stable dose is defined as a dose within 25% of the dose at Baseline
Exclusion
Exclusion Criteria:
Participants who have been treated with systemic immunosuppressive medicationsincluding glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO®commercial treatment period. Topical or inhalation products containing GCS orimmunosuppressants are allowed
Presence of other glomerulopathies (e.g., C3 glomerulopathy and/or diabetesnephropathy)
Presence of nephrotic syndrome (i.e., proteinuria >3.5 g per day and serum albumin <3.0 g/dL, with or without edema)
Presence of medical condition excluding continued TARPEYO® treatment, as assessed bythe Investigator
On current or planned dialysis.
Undergone kidney transplant.
Poorly controlled diabetes mellitus or hypertension, as assessed by theInvestigator.
Participants with known osteoporosis in the medium- or high-risk category accordingto the 2010 American College of Rheumatology recommendations.
Any medical or social circumstance making trial participation and/or TARPEYO®treatment unsuitable, as assessed by the Investigator.
Participants with clinically significant infections that put the participant atrisk, at the discretion of the Investigator.
Participants unwilling or unable to meet the requirements of the protocol.
Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.
Females who are pregnant, breastfeeding, or plan to become pregnant in the trialperiod.
Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4
Study Design
Study Description
Connect with a study center
Advanced Renal Care Institute
Mayagüez 4566385, 00680
Puerto RicoActive - Recruiting
Univ of Alabama/Birmingham
Birmingham, Alabama 35297
United StatesSite Not Available
Univ of Alabama/Birmingham
Birmingham 4049979, Alabama 4829764 35297
United StatesActive - Recruiting
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale, Arizona 85306
United StatesSite Not Available
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale 5295985, Arizona 5551752 85306
United StatesActive - Recruiting
The Medical Research Group, Inc.
Fresno 5350937, California 5332921 93720
United StatesActive - Recruiting
UCI Health-UCI Medical Center
Orange 5379513, California 5332921 92868
United StatesActive - Recruiting
Loma Linda University
San Bernardino 5391710, California 5332921 92408
United StatesActive - Recruiting
UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Stanford University
Stanford 5398563, California 5332921 94305
United StatesActive - Recruiting
University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Yale University Nephrology Clinical Trials Program
New Haven, Connecticut 06510
United StatesSite Not Available
Yale University Nephrology Clinical Trials Program
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
Florida Kidney Physicians
Boca Raton, Florida 33431
United StatesSite Not Available
Florida Kidney Physicians
Boca Raton 4148411, Florida 4155751 33431
United StatesActive - Recruiting
Central Florida Kidney Specialists
Orlando 4167147, Florida 4155751 32819
United StatesActive - Recruiting
Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904
United StatesSite Not Available
Cobb Nephrology Hypertension Associates, PC
Austell, Georgia 30106
United StatesSite Not Available
Southeastern Clinical Research Institute, LLC
Augusta 4180531, Georgia 4197000 30904
United StatesActive - Recruiting
Cobb Nephrology Hypertension Associates, PC
Austell 4180564, Georgia 4197000 30106
United StatesActive - Recruiting
Georgia Nephrology
Lawrenceville 4205196, Georgia 4197000 30046
United StatesActive - Recruiting
University of Louisville
Louisville 4299276, Kentucky 6254925 40208
United StatesActive - Recruiting
Ochsner Health, New Orleans
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Health, New Orleans
New Orleans 4335045, Louisiana 4331987 70121
United StatesActive - Recruiting
University of Maryland Division of Nephrology
Baltimore 4347778, Maryland 4361885 21201
United StatesActive - Recruiting
Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine
Boston 4930956, Massachusetts 6254926 02118
United StatesActive - Recruiting
Washington University in St. Louis
Saint Louis Park, Minnesota 63110
United StatesSite Not Available
University of Minnesota Health Fairview
Minneapolis 5037649, Minnesota 5037779 55455
United StatesActive - Recruiting
Washington University in St. Louis
St Louis 4407066, Missouri 4398678 63130
United StatesActive - Recruiting
Renal Medical Associates
Albuquerque, New Mexico 87109
United StatesSite Not Available
Renal Medical Associates
Albuquerque 5454711, New Mexico 5481136 87109
United StatesActive - Recruiting
University of New Mexico
Albuquerque 5454711, New Mexico 5481136 87106
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Chinatown Kidney Care, PLLC
New York City, New York 10013
United StatesSite Not Available
New York Nephrology Vasculitis and Glomerular Center
Clifton Park 5112961, New York 5128638 12065
United StatesActive - Recruiting
Chinatown Kidney Care, PLLC
New York 5128581, New York 5128638 10013
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Ohio State University
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
University of Pennsylvania Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Dallas Renal Group
Dallas, Texas 75230
United StatesSite Not Available
MedResearch Inc
El Paso, Texas 79902
United StatesSite Not Available
The University of Texas Medical Branch UTMB
Galveston, Texas 77555
United StatesSite Not Available
Memorial Hermann Houston
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesSite Not Available
The Kidney Institute/Houston
Houston, Texas 77090
United StatesActive - Recruiting
Dallas Nephrology Associates McKinney
McKinney, Texas 75069
United StatesSite Not Available
Permian Basin Kidney Center
Odessa, Texas 79761
United StatesSite Not Available
Dallas Renal Group
Dallas 4684888, Texas 4736286 75230
United StatesActive - Recruiting
MedResearch Inc
El Paso 5520993, Texas 4736286 79902
United StatesActive - Recruiting
The University of Texas Medical Branch UTMB
Galveston 4692883, Texas 4736286 77555
United StatesActive - Recruiting
Memorial Hermann Houston
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston 4699066, Texas 4736286 77054
United StatesActive - Recruiting
The Kidney Institute/Houston
Houston 4699066, Texas 4736286 77090
United StatesActive - Recruiting
Dallas Nephrology Associates McKinney
McKinney 4710178, Texas 4736286 75069
United StatesActive - Recruiting
Permian Basin Kidney Center
Odessa 5527554, Texas 4736286 79761
United StatesActive - Recruiting

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