IgA Nephropathy (IgAN)Phase 3LUMINA IgANNCT07850752
A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy
A Phase 3 study testing zigakibart and atrasentan in people with IgA Nephropathy (IgAN), run by Novartis Pharmaceuticals.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- zigakibart and atrasentan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 25 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Diagnosis of active IgA vasculitis
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
About this study
Official title: 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
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.
Read the detailed description
The study includes a 52-week double-blind treatment period and a 52-week open-label extension (OLE):
- Double-blind treatment period: Participants will receive zigakibart and either atrasentan or matching placebo. The purpose is to evaluate if zigakibart + atrasentan demonstrates increased efficacy in reducing proteinuria and delaying progression of disease compared to zigakibart + placebo. It also aims to evaluate the safety and tolerability of zigakibart + atrasentan.
- OLE: Participants will receive zigakibart and atrasentan. The purpose is to provide study participants with the opportunity to continue to receive zigakibart and atrasentan, while enabling continued collection of long-term efficacy, safety, and tolerability data.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- zigakibart, atrasentan, Placebo
- Keywords
- Zigakibart, Atrasentan, IgA nephropathy, IgAN, Proteinuria, UPCR, eGFR, eGFR slope, Kidney function decline
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zigakibartBiological
Also called BION-1301, FUB523
Solution for injection via PFS-NSD
atrasentanDrug
Also called CHK01, EXV811
Tablet
PlaceboDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| zigakibart + atrasentan | Experimental | Patients receive zigakibart and atrasentan Receives: Biological: zigakibart; Drug: atrasentan |
| zigakibart + placebo | Active comparator | Patients receive zigakibart and matching placebo Receives: Biological: zigakibart; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection
Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction
Measured: Baseline, Week 36
Secondary outcomes (5)
Rate of patients achieving proteinuria remission at Week 52
Difference between the treatment groups in the rate of patients achieving proteinuria remission, defined as 24-hour UPCR < 0.5 g/g
Measured: Week 52
Rate of proteinuria remission
Difference between the treatment groups in the rate of proteinuria remission, defined as 24-hour UPCR of < 0.3 g/g
Measured: Week 52
Proportion of participants with AEs, SAEs and AESIs
Proportion of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of special interest (AESIs)
Measured: 128 Weeks
Change from baseline in Glomerular Filtration rate (GFR)
Change from baseline in GFR (safety laboratory parameters)
Measured: Baseline and up to 104 weeks
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in SBP and DBP (vital signs)
Measured: Baseline and up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion17 Sep 2028 (estimated)
- Study completion25 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850752
- Sponsor's protocol ID
- CFUB523A12303
- Acronym
- LUMINA IgAN
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07850752
- Acronym / sponsor ID
- LUMINA IgAN / CFUB523A12303
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- Zigakibart, Atrasentan, IgA nephropathy, IgAN, Proteinuria, UPCR, eGFR, eGFR slope
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 17 Sep 2028 (estimated)
- Study completion
- 25 Dec 2030 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study includes a 52-week double-blind treatment period and a 52-week open-label extension (OLE):
- Double-blind treatment period: Participants will receive zigakibart and either atrasentan or matching placebo. The purpose is to evaluate if zigakibart + atrasentan demonstrates increased efficacy in reducing proteinuria and delaying progression of disease compared to zigakibart + placebo. It also aims to evaluate the safety and tolerability of zigakibart + atrasentan.
- OLE: Participants will receive zigakibart and atrasentan. The purpose is to provide study participants with the opportunity to continue to receive zigakibart and atrasentan, while enabling continued collection of long-term efficacy, safety, and tolerability data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zigakibart + atrasentan | Experimental | Biological: zigakibart, Drug: atrasentanPatients receive zigakibart and atrasentan |
| zigakibart + placebo | Active comparator | Biological: zigakibart, Drug: PlaceboPatients receive zigakibart and matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
- Diagnosis of active IgA vasculitis
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zigakibartAlso: BION-1301, FUB523Solution for injection via PFS-NSD | Biological | zigakibart + atrasentan, zigakibart + placebo |
| atrasentanAlso: CHK01, EXV811Tablet | Drug | zigakibart + atrasentan |
| PlaceboTablet | Drug | zigakibart + placebo |
Primary outcome
Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection
Time frame: Baseline, Week 36
Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction
5 secondary outcomes
Rate of patients achieving proteinuria remission at Week 52
Time frame: Week 52
Rate of proteinuria remission
Time frame: Week 52
Proportion of participants with AEs, SAEs and AESIs
Time frame: 128 Weeks
Change from baseline in Glomerular Filtration rate (GFR)
Time frame: Baseline and up to 104 weeks
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline and up to 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zigakibart and atrasentan in people with IgA Nephropathy (IgAN), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection (time frame: Baseline, Week 36). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.