Immunoglobulin A Nephropathy
Conditions
Brief summary
1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36]., 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].
Detailed description
1. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 2. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or death from kidney failure. [Time Frame: From Baseline Through Week 104]., 3. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104 [Time Frame: From Baseline at Week 104].
Interventions
DRUGTest IMP ALPN-303 pre-filled syringe without active substance
Sponsors
Alpine Immune Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36]., 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104]. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 2. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or death from kidney failure. [Time Frame: From Baseline Through Week 104]., 3. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104 [Time Frame: From Baseline at Week 104]. | — |
Countries
Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, Sweden
Outcome results
None listed