Rapidly progressive glomerulonephritis
Conditions
Brief summary
The primary endpoint for this study is the safety and tolerability of ALE.F02 when administered as a continuous IV infusion in patients with RPGN attributed to AAV. Safety endpoints are the following: - All AEs; - All SAEs; - Hematology and clinical chemistry analyte assessments; - Serum lipids; - Antidrug antibodies (ADAs); and - ECGs.
Detailed description
1. The key secondary endpoint for this study is the change in mean eGFR from baseline to Week 24/EOT for recipients of ALE.F02 compared to placebo., 2. Change in mean urine protein to creatinine ratio (UPCR) AUC from baseline to Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo;, 3. Time to stable proteinuria (≤0.5 g/day for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;, 4. Time to stable hematuria (≤5 RBCs/high-power field for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;, 5. Incidence of RRT at any time during the study for recipients of ALE.F02 compared to placebo; and, 6. Total glucocorticoid and immunosuppressive exposure at Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo.
Interventions
DRUG-
DRUGTest IMP (ALE.F02) without active substance
DRUGLIXUDEBART
DRUGRITUXIMAB
DRUGCYCLOPHOSPHAMIDE
Sponsors
Alentis Therapeutics AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this study is the safety and tolerability of ALE.F02 when administered as a continuous IV infusion in patients with RPGN attributed to AAV. Safety endpoints are the following: - All AEs; - All SAEs; - Hematology and clinical chemistry analyte assessments; - Serum lipids; - Antidrug antibodies (ADAs); and - ECGs. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The key secondary endpoint for this study is the change in mean eGFR from baseline to Week 24/EOT for recipients of ALE.F02 compared to placebo., 2. Change in mean urine protein to creatinine ratio (UPCR) AUC from baseline to Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo;, 3. Time to stable proteinuria (≤0.5 g/day for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;, 4. Time to stable hematuria (≤5 RBCs/high-power field for ≥14 days) during the Treatment Period for recipients of ALE.F02 compared to placebo;, 5. Incidence of RRT at any time during the study for recipients of ALE.F02 compared to placebo; and, 6. Total glucocorticoid and immunosuppressive exposure at Week 24/EOT and Week 52/EOS for recipients of ALE.F02 compared to placebo. | — |
Countries
Czechia, Denmark, France, Germany, Italy, Spain, Sweden
Outcome results
None listed