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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002345-64 | EudraCT Number |
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The purpose of this study is to assess the efficacy and safety of SM101 in the treatment of Immunoglobulin A nephropathy (IgAN)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SM101 12 mg/kg | Experimental | Human soluble recombinant Fcγ Receptor IIB |
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| SM101 24 mg/kg | Experimental | Human soluble recombinant Fcγ Receptor IIB |
|
| Placebo | Placebo Comparator | L-histidine-buffered saline with mannitol, sucrose, and polysorbate 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SM101 | Biological | Human soluble recombinant Fcγ Receptor IIB |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent change in proteinuria from Baseline to Week 24 | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who demonstrate a ≥30% reduction from Baseline in proteinuria | Baseline, Week 8, Week 12, Week 18, and Week 24 | |
| Number of participants who reach and maintain proteinuria levels below 1.0 g/24 h | Week 8, Week 12, Week 18, and Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Placebo | Other | L-histidine-buffered saline with mannitol, sucrose, and polysorbate 20 |
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| Mean change from Baseline in Estimated glomerular filtration rate (eGFR) | Baseline, Week 8, Week 12, Week 18, and Week 24 |
| Number of participants who experience any treatment-related serious adverse event (SAE) or severe adverse events (AE) during the course of the treatment period or subsequent follow-up period | Throughout the study period of approximately 19 months |
| Number of participants who experience serious adverse events (SAEs) or adverse events (AEs) | Throughout the study period of approximately 19 months |
| Number of participants who experience temporally-related adverse events (AEs) | Temporally-related AEs - defined as AEs occurring during investigational product (IP) administration or within 72 hours of IP administration, regardless of causality | Baseline through 72 hours of IP administration |
| Number of participants with any clinically significant change in vital signs during investigational product (IP) administration or within 30 minutes following administration | Baseline through 30 minutes following IP administration |
| Number of infusions associated with adverse events (AEs) or serious adverse events (SAEs) , regardless of causality | Throughout the study period of approximately 19 months |
| Number of infusions that had to be slowed, interrupted, or terminated due to adverse events (AEs) or serious adverse events (SAEs) | Throughout the study period of approximately 19 months |
| Number of participants with detectable levels of antidrug antibodies (ADAs) | Baseline, Week 3, Week 4, Week 12, Week 24, or early termination from the study |
| Clinically significant abnormal laboratory assessments | Throughout the study period of approximately 19 months |
| Pharmacokinetics: maximum observed concentration (Cmax) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: time of maximum observed concentration (Cmax) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: area under the concentration-time curve during a dosing interval (AUC(0-tau)) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: terminal half-life (t1/2) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: systemic clearance (CL) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: volume of distribution at the terminal phase (Vz) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| Pharmacokinetics: volume of distribution at steady state (Vss) | Week 1 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 8 or 12, 24, 48 or 72, and 168 hours. Week 4 within 30 minutes pre-infusion, and post-infusion 0.5, 1, 2, 4, 24, and 168 hours. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |