Actively Recruiting
An Open-label Study 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
Led by Calliditas Therapeutics AB · Updated on 2026-02-05
60
Participants Needed
38
Research Sites
74 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
This trial focuses on adults with primary IgA nephropathy (IgAN) who have already completed 9 months of treatment with TARPEYO4 (delayed-release budesonide capsules) at 16 mg once daily in regular clinical practice. The study aims to determine if continuing TARPEYO4 treatment provides further benefits in reducing proteinuria and protecting kidney function over a longer period. This is a phase 4, open-label study sponsored by Calliditas Therapeutics AB. Participants will undergo an extended treatment regimen lasting about 15 months, starting with 6 months of TARPEYO4 16 mg once daily, followed by 9 months of TARPEYO4 8 mg once daily. After this, there will be a 3-month follow-up period, including a 2-week tapering phase with TARPEYO4 4 mg once daily. The goal is to maintain or improve treatment effects while reducing dosage gradually. During the study, participants will have urine tests, blood samples, and physical exams at regular intervals to monitor kidney function and protein levels. Researchers will measure the urine protein to creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) at various points, assessing safety by tracking adverse events over approximately 19 months. The study includes thorough follow-up to evaluate the ongoing impact of extended TARPEYO4 use.
CONDITIONS
Brief 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 IgA nephropathy confirmed by biopsy
- Female or male participants aged 18 years or older
- Completion of a single 9-month treatment with TARPEYO 16 mg once daily at baseline
- Access to retrospective local laboratory data on urine protein to creatinine ratio and serum creatinine
- On stable renin-angiotensin system inhibitor therapy or sparsentan for at least 8 weeks before baseline
- If using sodium-glucose cotransporter-2 inhibitor, treatment must be stable for at least 8 weeks before baseline
You will not qualify if you...
- Treatment with systemic immunosuppressive medications other than TARPEYO during prior TARPEYO treatment
- Presence of other glomerulopathies such as C3 glomerulopathy, diabetic or hypertensive nephropathy
- Presence of nephrotic syndrome with proteinuria over 3.5 g/day and serum albumin below 3.0 g/dL
- Medical conditions preventing continued TARPEYO treatment
- Current or planned dialysis
- Previous kidney transplant
- Poorly controlled diabetes or hypertension
- Known osteoporosis in medium or high-risk category
- Any medical or social conditions making participation or treatment unsuitable
- Clinically significant infections posing risk
- Unwillingness or inability to follow study protocol
- Use of other investigational drugs during or before prior TARPEYO treatment
- Females who are pregnant, breastfeeding, or planning pregnancy during the trial
- Use of potent cytochrome P450 3A4 inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 months
Participants receive extended TARPEYO® treatment to improve and maintain kidney function and reduce proteinuria.
Visits occur throughout the 6-month period with TARPEYO® 16 mg once daily followed by 9 months with TARPEYO® 8 mg once daily
Duration - 3 months
Participants undergo a 3-month follow-up period including a 2-week tapering with TARPEYO® 4 mg once daily.
Visits during tapering period and follow-up assessments
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
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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