Actively Recruiting
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Led by Calliditas Therapeutics AB · Updated on 2026-02-05
60
Participants Needed
38
Research Sites
149 weeks
Total Duration
On this page
Sponsors
C
Calliditas Therapeutics AB
Lead Sponsor
W
Worldwide Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is: Is there a treatment benefit of TARPEYO® 16 mg QD extended use? Participants will * take part in this study for about 19 months * Have urine tests done * Have blood samples taken * Have physical examinations done
CONDITIONS
Official Title
Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed IgAN confirmed by biopsy
- Male or female participants aged 18 years or older
- Completed a single 9-month treatment with TARPEYO4 16 mg once daily at Baseline visit
- Access to retrospective local lab data on urine protein to creatinine ratio (UPCR) and serum creatinine, including at least one assessment within 3 months before first TARPEYO4 dose
- On stable renin-angiotensin system (RAS) inhibitor therapy or sparsentan for at least 8 weeks before Baseline visit, with dose stable within 25%
- If on sodium-glucose cotransporter-2 (SGLT2) inhibitors, treatment stable for at least 8 weeks before Baseline visit, dose stable within 25%
You will not qualify if you...
- Treated with systemic immunosuppressive medications including glucocorticosteroids other than TARPEYO4 during TARPEYO4 commercial treatment period (topical/inhalation allowed)
- Other glomerulopathies such as C3 glomerulopathy, diabetic nephropathy, or hypertensive nephropathy
- Nephrotic syndrome with proteinuria >3.5 g/day and serum albumin <3.0 g/dL, with or without edema
- Any medical condition preventing continued TARPEYO4 treatment as assessed by Investigator
- Currently on or planned for dialysis
- History of kidney transplant
- Poorly controlled diabetes mellitus or hypertension per Investigator
- Known osteoporosis in medium- or high-risk category per 2010 American College of Rheumatology
- Any medical or social condition making trial participation or TARPEYO4 treatment unsuitable
- Clinically significant infections posing risk as judged by Investigator
- Unwilling or unable to meet protocol requirements
- Use of another investigational drug during trial or preceding 9-month TARPEYO4 treatment
- Females who are pregnant, breastfeeding, or planning pregnancy during trial
- Taking potent inhibitors of cytochrome P450 (CYP) 3A4 enzymes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 38 locations
1
Univ of Alabama/Birmingham
Birmingham, Alabama, United States, 35297
Actively Recruiting
2
Arizona Kidney Disease & Hypertension Centers (AKDHC)
Glendale, Arizona, United States, 85306
Actively Recruiting
3
The Medical Research Group, Inc.
Fresno, California, United States, 93720
Actively Recruiting
4
UCI Health-UCI Medical Center
Orange, California, United States, 92868
Actively Recruiting
5
Loma Linda University
San Bernardino, California, United States, 92408
Actively Recruiting
6
UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice
San Francisco, California, United States, 94143
Actively Recruiting
7
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
8
University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location
Aurora, Colorado, United States, 80045
Actively Recruiting
9
Yale University Nephrology Clinical Trials Program
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Florida Kidney Physicians
Boca Raton, Florida, United States, 33431
Actively Recruiting
11
Central Florida Kidney Specialists
Orlando, Florida, United States, 32819
Actively Recruiting
12
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, United States, 30904
Actively Recruiting
13
Cobb Nephrology Hypertension Associates, PC
Austell, Georgia, United States, 30106
Actively Recruiting
14
Georgia Nephrology
Lawrenceville, Georgia, United States, 30046
Actively Recruiting
15
University of Louisville
Louisville, Kentucky, United States, 40208
Actively Recruiting
16
Ochsner Health, New Orleans
New Orleans, Louisiana, United States, 70121
Actively Recruiting
17
University of Maryland Division of Nephrology
Baltimore, Maryland, United States, 21201
Actively Recruiting
18
Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts, United States, 02118
Actively Recruiting
19
University of Minnesota Health Fairview
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
20
Washington University in St. Louis
St Louis, Missouri, United States, 63130
Actively Recruiting
21
University of New Mexico
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
22
Renal Medical Associates
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
23
New York Nephrology Vasculitis and Glomerular Center
Clifton Park, New York, United States, 12065
Actively Recruiting
24
Chinatown Kidney Care, PLLC
New York, New York, United States, 10013
Actively Recruiting
25
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
26
North Carolina Nephrology, P.A
Raleigh, North Carolina, United States, 27609
Actively Recruiting
27
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
28
Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic
Portland, Oregon, United States, 97239
Actively Recruiting
29
University of Pennsylvania Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Dallas Renal Group
Dallas, Texas, United States, 75230
Actively Recruiting
31
MedResearch Inc
El Paso, Texas, United States, 79902
Actively Recruiting
32
The University of Texas Medical Branch UTMB
Galveston, Texas, United States, 77555
Actively Recruiting
33
Memorial Hermann Houston
Houston, Texas, United States, 77054
Actively Recruiting
34
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
35
The Kidney Institute/Houston
Houston, Texas, United States, 77090
Actively Recruiting
36
Dallas Nephrology Associates McKinney
McKinney, Texas, United States, 75069
Actively Recruiting
37
Permian Basin Kidney Center
Odessa, Texas, United States, 79761
Actively Recruiting
38
Advanced Renal Care Institute
Mayagüez, Puerto Rico, 00680
Actively Recruiting
Research Team
A
Annette LeBlanc-Donahue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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