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      "canonicalId": "NCT06712407",
      "title": "Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy",
      "scientificTitle": "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 in Real-world Clinical Practice",
      "status": "active",
      "studyType": "interventional",
      "phase": [
        "PHASE4"
      ],
      "conditions": [
        "IgA Nephropathy"
      ],
      "interventions": [
        {
          "name": "TARPEYO®",
          "type": "DRUG",
          "description": "6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering."
        }
      ],
      "sponsor": {
        "name": "Calliditas Therapeutics AB",
        "type": "INDUSTRY"
      },
      "locations": [
        {
          "city": "Birmingham",
          "country": "United States",
          "facility": "Univ of Alabama/Birmingham"
        },
        {
          "city": "Glendale",
          "country": "United States",
          "facility": "Arizona Kidney Disease & Hypertension Centers (AKDHC)"
        },
        {
          "city": "Fresno",
          "country": "United States",
          "facility": "The Medical Research Group, Inc."
        },
        {
          "city": "Orange",
          "country": "United States",
          "facility": "UCI Health-UCI Medical Center"
        },
        {
          "city": "San Bernardino",
          "country": "United States",
          "facility": "Loma Linda University"
        },
        {
          "city": "San Francisco",
          "country": "United States",
          "facility": "UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice"
        },
        {
          "city": "Stanford",
          "country": "United States",
          "facility": "Stanford University"
        },
        {
          "city": "Aurora",
          "country": "United States",
          "facility": "University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus Location"
        },
        {
          "city": "New Haven",
          "country": "United States",
          "facility": "Yale University Nephrology Clinical Trials Program"
        },
        {
          "city": "Boca Raton",
          "country": "United States",
          "facility": "Florida Kidney Physicians"
        },
        {
          "city": "Orlando",
          "country": "United States",
          "facility": "Central Florida Kidney Specialists"
        },
        {
          "city": "Augusta",
          "country": "United States",
          "facility": "Southeastern Clinical Research Institute, LLC"
        },
        {
          "city": "Austell",
          "country": "United States",
          "facility": "Cobb Nephrology Hypertension Associates, PC"
        },
        {
          "city": "Lawrenceville",
          "country": "United States",
          "facility": "Georgia Nephrology"
        },
        {
          "city": "Louisville",
          "country": "United States",
          "facility": "University of Louisville"
        },
        {
          "city": "New Orleans",
          "country": "United States",
          "facility": "Ochsner Health, New Orleans"
        },
        {
          "city": "Baltimore",
          "country": "United States",
          "facility": "University of Maryland Division of Nephrology"
        },
        {
          "city": "Boston",
          "country": "United States",
          "facility": "Boston Medical Center; Boston University Chobanian & Avedisian School of Medicine"
        },
        {
          "city": "Minneapolis",
          "country": "United States",
          "facility": "University of Minnesota Health Fairview"
        },
        {
          "city": "St Louis",
          "country": "United States",
          "facility": "Washington University in St. Louis"
        },
        {
          "city": "Albuquerque",
          "country": "United States",
          "facility": "University of New Mexico"
        },
        {
          "city": "Albuquerque",
          "country": "United States",
          "facility": "Renal Medical Associates"
        },
        {
          "city": "Clifton Park",
          "country": "United States",
          "facility": "New York Nephrology Vasculitis and Glomerular Center"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "Chinatown Kidney Care, PLLC"
        },
        {
          "city": "New York",
          "country": "United States",
          "facility": "Icahn School of Medicine at Mount Sinai"
        },
        {
          "city": "Raleigh",
          "country": "United States",
          "facility": "North Carolina Nephrology, P.A"
        },
        {
          "city": "Columbus",
          "country": "United States",
          "facility": "Ohio State University"
        },
        {
          "city": "Portland",
          "country": "United States",
          "facility": "Oregon Health & Science University (OHSU) - Nephrology and Hypertension Clinic"
        },
        {
          "city": "Philadelphia",
          "country": "United States",
          "facility": "University of Pennsylvania Philadelphia"
        },
        {
          "city": "Dallas",
          "country": "United States",
          "facility": "Dallas Renal Group"
        },
        {
          "city": "El Paso",
          "country": "United States",
          "facility": "MedResearch Inc"
        },
        {
          "city": "Galveston",
          "country": "United States",
          "facility": "The University of Texas Medical Branch UTMB"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "Memorial Hermann Houston"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "Prolato Clinical Research Center"
        },
        {
          "city": "Houston",
          "country": "United States",
          "facility": "The Kidney Institute/Houston"
        },
        {
          "city": "McKinney",
          "country": "United States",
          "facility": "Dallas Nephrology Associates McKinney"
        },
        {
          "city": "Odessa",
          "country": "United States",
          "facility": "Permian Basin Kidney Center"
        },
        {
          "city": "Mayagüez",
          "country": "Puerto Rico",
          "facility": "Advanced Renal Care Institute"
        }
      ],
      "outcomes": {
        "other": [],
        "primary": [
          "Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline"
        ],
        "secondary": [
          "Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline",
          "Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)",
          "Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to prior to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)",
          "Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline",
          "Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline",
          "Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)",
          "Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to start of TARPEYO® commercial treatment (i.e., comparison with retrospective local laboratory data from medical records as available)",
          "Ratio of 24-hour urine proteinuria at 6 months compared to Baseline",
          "Ratio of 24-hour urine proteinuria at 15 months compared to Baseline",
          "Proportion of participants with microhematuria at 6 months",
          "Proportion of participants with microhematuria at 15 months",
          "To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment"
        ]
      },
      "eligibility": {
        "sex": "ALL",
        "criteria": "Inclusion Criteria:\n\n1. Diagnosed IgAN with biopsy verification\n2. Female or male participants ≥18 years of age\n3. Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit\n4. Access to retrospective local laboratory assessment data on UPCR and serum creatinine. Available retrospective data should include at least 1 assessment timepoint within 3 months prior to the first dose of TARPEYO® commercial treatment.\n5. On stable treatment with renin-angiotensin system (RAS) inhibitor therapy or sparsentan 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.\n6. If on current treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitor, the treatment 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.\n\nExclusion Criteria:\n\n1. Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the TARPEYO® commercial treatment period. Topical or inhalation products containing GCS or immunosuppressants are allowed.\n2. Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy).\n3. Presence of nephrotic syndrome (i.e., proteinuria \\>3.5 g per day and serum albumin \\<3.0 g/dL, with or without edema).\n4. Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator.\n5. On current or planned dialysis.\n6. Undergone kidney transplant.\n7. Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.\n8. Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations.\n9. Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator.\n10. Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator.\n11. Participants unwilling or unable to meet the requirements of the protocol.\n12. Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period.\n13. Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period.\n14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4",
        "minimumAge": "18 Years",
        "healthyVolunteers": false
      },
      "enrollment": {
        "type": "ESTIMATED",
        "count": 60
      },
      "startDate": "2024-12-17",
      "completionDate": "2028-02-01",
      "lastUpdated": "2026-09-24T00:00:00.000Z",
      "firstPosted": "2024-12-02T00:00:00.000Z",
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