Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

Official title

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

Overview

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

Detailed description

This clinical trial will investigate the efficacy and safety of TARPEYO® treatment extended for an additional 15 months in adult IgAN participants who have completed their initial, single 9-month TARPEYO® 16 mg QD commercial treatment regimen. Participants with residual proteinuria will be eligible for enrollment. The Treatment Period will consist of a 6-month Treatment Period with TARPEYO® 16 mg QD, followed by a 9-month Treatment Period with TARPEYO® 8 mg QD. This will be followed by a 3-month Follow-up Period, which includes the first 2 weeks of Tapering Period with TARPEYO® 4 mg QD.

The overall aim of the extended treatment is to improve and maintain the treatment effect with reduced proteinuria and protection of kidney function over a total of 2 years of TARPEYO® treatment.

Interventions

• Drug TARPEYO®
  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.

Primary outcome measures

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline [Time frame: 6 months]

Secondary outcome measures (12)

• Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline [Time frame: 15 months]
• 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) [Time frame: 18 months]
• 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) [Time frame: 27 months]
• Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline [Time frame: 6 months]
• Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline [Time frame: 15 months]
• 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) [Time frame: 18 months]
• 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) [Time frame: 27 months]
• Ratio of 24-hour urine proteinuria at 6 months compared to Baseline [Time frame: 6 months]
• Ratio of 24-hour urine proteinuria at 15 months compared to Baseline [Time frame: 15 months]
• Proportion of participants with microhematuria at 6 months [Time frame: 6 months]
• Proportion of participants with microhematuria at 15 months [Time frame: 15 months]
• To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment [Time frame: 19 months]

Eligibility criteria

Inclusion criteria

• Diagnosed IgAN with biopsy verification
• Female or male participants ≥18 years of age
• Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit
• 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.
• 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.
• 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.

Exclusion criteria

• 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.
• Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy).
• 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 by the Investigator.
• On current or planned dialysis.
• Undergone kidney transplant.
• Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator.
• Participants with known osteoporosis in the medium- or high-risk category according to 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 at risk, 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 trial period.
• Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 37 centers

• Univ of Alabama/Birmingham — Birmingham
• Arizona Kidney Disease & Hypertension Centers (AKDHC) — Glendale
• The Medical Research Group, Inc. — Fresno
• UCI Health-UCI Medical Center — Orange
• Loma Linda University — San Bernardino
• UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice — San Francisco
• Stanford University — Stanford
• University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz — Aurora
• … and 29 more centers

Puerto Rico · 1 center

• Advanced Renal Care Institute — Mayagüez

Identifiers

NCT: NCT06712407 · Nef-403

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗