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The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zigakibart | Experimental | Participants will receive zigakibart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zigakibart | Drug | solution for subcutaneous injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events. | Number of participants with adverse events will be provided. | Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment |
| Number of participants with serious adverse events. | Number of participants with serious adverse events will be provided. | Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment |
| Number of participants with adverse events of special interest. | Number of participants with adverse events of special interest will be provided. | Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in UPCR from Baseline to Week 48 and Week 96. | The change in the ratio of urine protein to urine creatinine (UPCR), based on 24-hour urine collection, from Baseline to Week 48 and to Week 96. | Baseline visit, Week 48 and Week 96. |
| Change in eGFR from Baseline to Week 96. |
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Inclusion Criteria:
Exclusion Criteria:
Highly effective contraception methods for both women and men include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Kidney Care Nephrology | Recruiting | Denver | Colorado | 80230 | United States |
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Estimated glomerular filtration rate (eGFR) will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline and Week 96 timepoints will then be calculated. |
| Baseline visit and Week 96. |
| Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study. | eGFR will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline in the BEYOND study and Week 96 in OLE study will then be calculated. | Baseline visit and Week 96. |
| Serum concentration values of zigakibart at scheduled visits. | Serum concentration values will be provided for the following scheduled visits: Day 1, Week 24 and Week 96. | Baseline visit, Week 24 and Week 96. |
| Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels. | Immunoglobulin (IgA, IgG and IgM) levels will be assessed from samples collected at Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT. The change (difference) in immunoglobulin levels between Baseline and the noted timepoints will then be calculated. | Baseline visit, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT. |
| Presence of circulating binding and neutralizing anti- drug antibodies (ADA/Nab). | Number of participants with circulating binding and neutralizing anti-drug antibodies (ADA/Nab) in blood will be provided at the following scheduled visits: Day 1, Week 24, Week 96. | Baseline visit, Week 24 and Week 96. |
| Number of participants with abnormal safety laboratory parameters. | Number of participants with abnormal safety laboratory parameters will be provided. | Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years. |
| Number of participants with abnormal vital sign measurements. | Number of participants with abnormal vital sign measurements will be provided. | Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years. |
| Nephrology Associates Of Central FL | Recruiting | Orlando | Florida | 32806 | United States |
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| NY Nephrology | Recruiting | Clifton Park | New York | 12065 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Knoxville Kidney Center Pllc | Recruiting | Brentwood | Tennessee | 37027-4528 | United States |
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| Dallas Renal Group | Recruiting | Dallas | Texas | 75230 | United States |
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| Dallas Renal Group | Recruiting | Dallas | Texas | 75230 | United States |
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| Novartis Investigative Site | Recruiting | Caba | Buenos Aires | 3375 | Argentina |
| Novartis Investigative Site | Recruiting | La Plata | Buenos Aires | B1902COS | Argentina |
| Novartis Investigative Site | Recruiting | Buenos Aires | Buenos Aires F.D. | 1280 | Argentina |
| Novartis Investigative Site | Recruiting | Santa Fe | S3000EPV | Argentina |
| Novartis Investigative Site | Recruiting | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Recruiting | Kuantan | Pahang | 25100 | Malaysia |
| Novartis Investigative Site | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Recruiting | Cheonan | Chungcheongnam-do | 330-721 | South Korea |
| Novartis Investigative Site | Recruiting | Guri-si | Gyeonggi-do | 471-701 | South Korea |
| Novartis Investigative Site | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | Seoul | 03080 | South Korea |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D014570 | Urologic Diseases |
| D005921 | Glomerulonephritis |
| D005922 | Glomerulonephritis, IGA |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009393 | Nephritis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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