Phase
Condition
Nephropathy
Kidney Disease
Nephritis
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
Univ of Alabama/Birmingham
Birmingham, Alabama 35297
United StatesActive - Recruiting
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale, Arizona 85306
United StatesActive - Recruiting
Yale University Nephrology Clinical Trials Program
New Haven, Connecticut 06510
United StatesActive - Recruiting
Florida Kidney Physicians
Boca Raton, Florida 33431
United StatesActive - Recruiting
Southeastern Clinical Research Institute, LLC
Augusta, Georgia 30904
United StatesActive - Recruiting
Cobb Nephrology Hypertension Associates, PC
Austell, Georgia 30106
United StatesActive - Recruiting
Ochsner Health, New Orleans
New Orleans, Louisiana 70121
United StatesActive - Recruiting
Washington University in St. Louis
Saint Louis Park, Minnesota 63110
United StatesActive - Recruiting
Renal Medical Associates
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesActive - Recruiting
Chinatown Kidney Care, PLLC
New York City, New York 10013
United StatesActive - Recruiting
Dallas Renal Group
Dallas, Texas 75230
United StatesActive - Recruiting
MedResearch Inc
El Paso, Texas 79902
United StatesActive - Recruiting
The University of Texas Medical Branch UTMB
Galveston, Texas 77555
United StatesActive - Recruiting
Memorial Hermann Houston
Houston, Texas 77054
United StatesActive - Recruiting
Prolato Clinical Research Center
Houston, Texas 77054
United StatesActive - Recruiting
The Kidney Institute/Houston
Houston, Texas 77090
United StatesActive - Recruiting
Dallas Nephrology Associates McKinney
McKinney, Texas 75069
United StatesActive - Recruiting
Permian Basin Kidney Center
Odessa, Texas 79761
United StatesActive - Recruiting
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