Clinical Trials in Italy / NCT05852938
Active, not recruiting
Phase 3
A Study of Zigakibart in Adults With IgA Nephropathy
NCT05852938 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
IgA NephropathyImmunoglobulin A Nephropathy
Investigational drug(s) / intervention(s)
BION-1301 →Placebo
BION-1301: BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.
Placebo: Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.
Study summary
Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy
Eligibility
Inclusion Criteria:
* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.
Exclusion Criteria:
* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* IgG levels \< 6 g/L at Screening.
Other protocol-defined inclusion/exclusion criteria may apply
Primary outcome measure(s)
- Change from baseline in eGFR — Baseline and 104 weeks or approximately 2 years
Change from Baseline to Week 104 in eGFR using the CKD-EPI 2021 creatinine equation
Trial sites (200)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham: The Kirklin Clinic | Birmingham | Alabama | |
| Nephrology Consultants, LLC | Huntsville | Alabama | |
| University of California, San Francisco | San Francisco | California | |
| Valiance Clinical Research | South Gate | California | |
| University of Colorado Hospital | Aurora | Colorado | |
| Denver Nephrology Research Division | Denver | Colorado | |
| Vida Medical Centers - Pembroke Pines | Pembroke Pines | Florida | |
| NorthShore University HealthSystem | Evanston | Illinois | |
| Nephrology Associales of Northern Illinois and Indiana | Hinsdale | Illinois | |
| Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd | Fort Wayne | Indiana | |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | |
| Intermed Consultants | Edina | Minnesota | |
| Capital District Renal Physicians | Clifton Park | New York | |
| Nephrology Associates PC - Flushing | Flushing | New York | |
| Icahn School of Medicine at Mount Sinai | New York | New York | |
| University of Cincinnati College of Medicine - 231 Albert Sabin Way | Cincinnati | Ohio | |
| Cleveland Clinic-9500 Euclid Ave | Cleveland | Ohio | |
| OHSU - Oregon Clinical and Translational Research Institute | Portland | Oregon | |
| Northeast Clinical Research Center, LLC | Bethlehem | Pennsylvania | |
| Columbia Nephrology Associates , P.A. - Columbia | Columbia | South Carolina | |
| Knoxville Kidney Center, PLLC - Frenova F1 | Knoxville | Tennessee | |
| Dallas Renal Group - 1411 N Beckley Ave | Dallas | Texas | |
| Dallas Renal Group - Waxachie - 2460 N. I-35 | Dallas | Texas | |
| DaVita Clinical Research | El Paso | Texas | |
| University of Texas MD Anderson Cancer Center-1155 Pressler | Houston | Texas | |
| East Texas Nephrology Associates | Lufkin | Texas | |
| Nephrology Associates of Northern Virginia-8501 Arlington Blvd | Fairfax | Virginia | |
| Swedish Center for Comprehensive Care | Seattle | Washington | |
| Novartis Investigative Site | La Plata | Buenos Aires | |
| Novartis Investigative Site | Catamarca | Catamarca Province | |
| Novartis Investigative Site | Barracas | Ciudad Autónoma de BuenosAires | |
| Novartis Investigative Site | Rosario | Santa Fe Province | |
| Novartis Investigative Site | Santa Fe | Santa Fe Province | |
| Novartis Investigative Site | Buenos Aires | Argentina | |
| Novartis Investigative Site | Gosford | New South Wales | |
| Novartis Investigative Site | Kogarah | New South Wales | |
| Novartis Investigative Site | Liverpool | New South Wales | |
| Novartis Investigative Site | Penrith | New South Wales | |
| Novartis Investigative Site | St Leonards | New South Wales | |
| Novartis Investigative Site | Cairns North | Queensland |
+ 160 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in Italy
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Other trials for the same condition
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
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Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05852938 on ClinicalTrials.gov ↗ ← All trials in Italy