NCT07850752Not yet recruitingPhase 3
A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy
A Phase IIIb, Multi-center, Two-arm, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Zigakibart and Atrasentan Versus Zigakibart and Placebo in Patients With Primary IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of disease progression.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 23 Sept 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 17 Sept 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- IgA nephropathy
- NCT number
- NCT07850752
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 340
- From 1 Dec 2026 to the primary completion date, 17 Sept 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic Kidney Disease (CKD), either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN
- Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasia
- Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (2025)
- Current clinical diagnosis of nephrotic syndrome
- Known history of heart failure or conditions relating to fluid overload such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites
- Current severe infection requiring antimicrobials, or history of recurrent, severe infections as determined by the Investigator
- Other protocol-defined inclusion/exclusion criteria may apply
Other
- Diagnosis of active IgA vasculitis
Who the study is looking for
- Aged ≥ 18 years at the time of signing the informed consent, 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. If a biopsy report within 10 years is not available, re-biopsy may be performed locally during Screening.
- eGFR ≥ 30 mL/min/1.73m2 by a central laboratory at Screening, calculated using serum creatinine based on the 2021 CKD-EPI equation (Inker et al 2021)
- UPCR ≥ 0.7 g/g (700 mg/g), as measured from a 24 hour urine collection by a central laboratory at Screening
- Stable on a maximally tolerated dose of ACEi and/or 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 SGLT2i, MRA, and/or GLP-1A if stable for at least 12 weeks prior to Screening. Participants are expected to stay on a stable dose of ACEi, ARB, SGLT2i, MRA and/or GLP-1A for the duration of the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.