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The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN1720 | Experimental | Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1720 | Drug | All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of ALXN1720 | Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events | Day 1 (Predose) through Follow-up (Day 92) | |
| Serum Concentration of Free and Total Complement Component 5 (C5) | Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site 2 | Anyang-si | Gyeonggi-do | 14068 | South Korea | ||
| Clinical Trial Site 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805697 | Derived | Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print. |
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Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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| ID | Term |
|---|---|
| D011507 | Proteinuria |
| D051436 | Renal Insufficiency, Chronic |
| D008181 | Lupus Nephritis |
| D005922 | Glomerulonephritis, IGA |
| D005923 | Glomerulosclerosis, Focal Segmental |
| D003928 | Diabetic Nephropathies |
| D009402 | Nephrosis, Lipoid |
| C562476 | Hematuria, Benign Familial |
| D015432 | Glomerulonephritis, Membranoproliferative |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720 | Day 1 (predose) through Day 57 |
| Seoul |
| 03080 |
| South Korea |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D009401 | Nephrosis |