IgA Nephropathy
Conditions
Keywords
TARPEYO®, IgAN, urine protein-to-creatinine, ESRD, Nefecon
Brief summary
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
DRUGTARPEYO®
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.
Sponsors
Calliditas Therapeutics AB
Worldwide Clinical Trials
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There are 2 treatment periods with the study drug: * TARPEYO® 16 mg (4 capsules) once a day for 6 months * TARPEYO® 8 mg (2 capsules) once a day for 9 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed IgAN with biopsy verification 2. Female or male participants ≥18 years of age 3. Completion of a single, initial 9 months of treatment with TARPEYO® 16 mg QD at the Baseline visit 4. 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. 5. 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. 6. 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
1. 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. 2. Presence of other glomerulopathies (e.g., C3 glomerulopathy, diabetes nephropathy and/or hypertensive nephropathy). 3. Presence of nephrotic syndrome (i.e., proteinuria \>3.5 g per day and serum albumin \<3.0 g/dL, with or without edema). 4. Presence of medical condition excluding continued TARPEYO® treatment, as assessed by the Investigator. 5. On current or planned dialysis. 6. Undergone kidney transplant. 7. Poorly controlled diabetes mellitus or hypertension, as assessed by the Investigator. 8. Participants with known osteoporosis in the medium- or high-risk category according to the 2010 American College of Rheumatology recommendations. 9. Any medical or social circumstance making trial participation and/or TARPEYO® treatment unsuitable, as assessed by the Investigator. 10. Participants with clinically significant infections that put the participant at risk, at the discretion of the Investigator. 11. Participants unwilling or unable to meet the requirements of the protocol. 12. Intake of another investigational drug during trial, or during the preceding 9-monthcommercial TARPEYO® treatment period. 13. Females who are pregnant, breastfeeding, or plan to become pregnant in the trial period. 14. Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline | 6 months | The outcome is measured as UPCR (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 6 months in g/gram divided with UPCR at Baseline in g/gram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of Urine Protein to Creatine Ratio (UPCR) at 15 months compared to Baseline | 15 months | The outcome is measured as UPCR (based on 24-hour urine collection) at 15 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being UPCR at 15 months in g/gram divided with UPCR at Baseline in g/gram. |
| 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) | 18 months | Ratio of UPCR (based on 24-hour urine collection) 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). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram |
| 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) | 27 months | Ratio of UPCR (based on 24-hour urine collection) 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). Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. Ratio being UPCR at 6 months in g/gram divided with UPCR prior to commercial treatment in g/gram |
| Ratio of estimated glomerular filtration rate (eGFR) at 6 months compared to Baseline | 6 months | The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 6 months following the first dose of TARPEYO® trial treatment compared to study baseline. |
| Ratio of estimated glomerular filtration rate (eGFR) at 15 months compared to Baseline | 15 months | The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 15 months following the first dose of TARPEYO® trial treatment compared to study 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) | 18 months | The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 6 months following the first dose of TARPEYO® trial treatment compared to start of commercial treatment. Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. |
| 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) | 27 months | The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 15 months following the first dose of TARPEYO® trial treatment compared to start of commercial treatment. Retrospective data will be collected up to 3 months prior to start of commercial treatment and during the duration of the commercial treatment. |
| Ratio of 24-hour urine proteinuria at 6 months compared to Baseline | 6 months | The outcome is measured as proteinurea (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being proteinurea at 6 months in g/day divided with proteinurea at Baseline in g/day. |
| Ratio of 24-hour urine proteinuria at 15 months compared to Baseline | 15 months | The outcome is measured as proteinurea (based on 24-hour urine collection) at 6 months following the first dose of TARPEYO® trial treatment compared to study Baseline. Ratio being proteinurea at 15 months in g/day divided with proteinurea at Baseline in g/day. |
| Proportion of participants with microhematuria at 6 months | 6 months | Number of participants with microhematuria at 6 months divided by total number of participants. |
| Proportion of participants with microhematuria at 15 months | 15 months | Number of participants with microhematuria at 15 months divided by total number of participants. |
| To evaluate the safety (SAEs and AEs) of extended TARPEYO® treatment | 19 months | SAEs and AEs will be evaluated and reported. |
Countries
Puerto Rico, United States
Contacts
CONTACTAnnette LeBlanc-Donahue
STUDY_DIRECTORKrassimir Mitchev
Calliditas Therapeutics
Outcome results
None listed