A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients with IgA Nephropathy at Risk of Progressive Loss of Renal Function (The ALIGN Study)

Conditions

Immunoglobulin A Nephropathy (IgAN)

Brief summary

The change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection) from baseline to Week 36 (non-SGLT2i stratum).

Detailed description

Change from baseline to final study visit (Week 136, 4 weeks post end of treatment) in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum), Percent of subjects meeting the composite endpoint of experiencing at least one of the following during the study (non-SGLT2i stratum): 1) At least a 30% reduction in eGFR sustained for at least 30 days, 2) eGFR <15 mL/min/1.73m2, sustained for at least 30 days, 3) Chronic dialysis, ≥30 days, 4) Kidney transplantation, 5) All-cause mortality, Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36 and a 25% decrease in total urine protein from Baseline (non-SGLT2i stratum)., Open Label Extension: Change from OL Baseline to OL Week 36 in UPCR based on 24-hour urine collection, Open Label Extension: Change from OL Baseline to OL Week 52 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation

Related papers

No related papers found yet.

Interventions

DRUGPlacebo - Film coated tablet for oral use

DRUGatrasentan

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The change in proteinuria (urine protein:creatinine ratio [UPCR] based on 24-hour urine collection) from baseline to Week 36 (non-SGLT2i stratum).	—

Secondary

Measure	Time frame
Change from baseline to final study visit (Week 136, 4 weeks post end of treatment) in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum), Percent of subjects meeting the composite endpoint of experiencing at least one of the following during the study (non-SGLT2i stratum): 1) At least a 30% reduction in eGFR sustained for at least 30 days, 2) eGFR <15 mL/min/1.73m2, sustained for at least 30 days, 3) Chronic dialysis, ≥30 days, 4) Kidney transplantation, 5) All-cause mortality, Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36 and a 25% decrease in total urine protein from Baseline (non-SGLT2i stratum)., Open Label Extension: Change from OL Baseline to OL Week 36 in UPCR based on 24-hour urine collection, Open Label Extension: Change from OL Baseline to OL Week 52 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation	—

Measure

Time frame

Change from baseline to final study visit (Week 136, 4 weeks post end of treatment) in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation (non-SGLT2i stratum), Percent of subjects meeting the composite endpoint of experiencing at least one of the following during the study (non-SGLT2i stratum): 1) At least a 30% reduction in eGFR sustained for at least 30 days, 2) eGFR <15 mL/min/1.73m2, sustained for at least 30 days, 3) Chronic dialysis, ≥30 days, 4) Kidney transplantation, 5) All-cause mortality, Percent of subjects achieving reduction of proteinuria to < 1 g/day at Week 36 and a 25% decrease in total urine protein from Baseline (non-SGLT2i stratum)., Open Label Extension: Change from OL Baseline to OL Week 36 in UPCR based on 24-hour urine collection, Open Label Extension: Change from OL Baseline to OL Week 52 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation

—

Countries

France, Germany, Italy, Poland, Portugal, Spain

Outcome results

None listed