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Tests treatment safety and results for IgA Nephropathy
Official title Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy
ClinicalTrials.gov ID: NCT06712407
What this study is testing
What is TARPEYO®?
TARPEYO® is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for iga nephropathy.
Also referred to as delayed-release budesonide capsules.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
- Time commitment: about 19 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- On stable treatment with renin-angiotensin system (RAS) inhibitor therapy or sparsentan for at least 8 weeks prior to the Baseline visit. A stable...
You likely can't join if
- Participants who have been treated with systemic immunosuppressive medications including glucocorticosteroids (GCS) other than TARPEYO® during the...
- 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.
See the full eligibility 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®...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Glendale, Arizona, United States
- Fresno, California, United States
- Orange, California, United States
- San Bernardino, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Austell, Georgia, United States
- Lawrenceville, Georgia, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 19 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Glendale, Arizona, United States; Fresno, California, United States; Orange, California, United States; San Bernardino, California, United States; San Francisco, California, United States and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.