IgA NephropathyPhase 3NCT07642050
A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy
A Phase 3 study testing BHV-1400 in people with IgA Nephropathy, run by Biohaven Therapeutics Ltd..
Trial summary
The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- BHV-1400
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.
- If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.
- In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.
- UPCR ≥ 0.75 g/g or UPE ≥ 1.0 g/d determined via 24 hour collection.
- eGFR ≥ 30 mL/min/1.73m2 (CKD-EPI equation).
- Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.
- Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.
Who cannot join
- Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.
- Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor/Sponsor Designee.
- Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.
- Evidence of nephrotic syndrome, defined as 24-hour protein > 3.5g with concurrent hypoalbuminemia (Albumin < 3.0 g/dl), within 6 months of Screening
- End-stage renal disease requiring dialysis or transplantation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy
The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
- Conditions
- IgA Nephropathy
- Being tested
- BHV-1400, Placebo
- Keywords
- IgAN, Chronic Kidney disease, Nephropathy, proteinuria, glomerulonephropathy, CKD, nephritis, urologic disease, glomerulonephritis, Glomerular disease, Iga nephropathy, renal disease, kidney disease
- Medical subject headings
- Glomerulonephritis, IGA, Renal Insufficiency, Chronic, Kidney Diseases, Proteinuria, Nephritis, Urologic Diseases, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1400Drug
500 mg delivered subcutaneously via autoinjector
PlaceboDrug
Matching placebo delivered subcutaneously via autoinjector
| Study group | Role | What they receive |
|---|---|---|
| BHV-1400 | Experimental | 500mg BHV-1400 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. Receives: Drug: BHV-1400 |
| Placebo | Placebo comparator | Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52
Measured: Baseline to Week 52
Secondary outcomes (12)
Change from baseline in GdIgA1 at Week 52
Measured: Baseline to Week 52
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Measured: Baseline to Week 52
Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase
Measured: Up to 52 weeks
Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase
Measured: Up to 52 weeks
Hematuria resolution at Week 52 (among participants with hematuria at baseline)
Measured: Baseline to Week 52
Proportion of study participants reaching a Urinary Protein Excretion (UPE) below 0.5 g/d at Week 52
Measured: Baseline to Week 52
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed during the DB Treatment Phase (up to 52 weeks)
Measured: Up to 52 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed during the DB Treatment Phase (up to 52 weeks)
Measured: Up to 52 Weeks
Change from baseline difference in the magnitude of the treatment effect (BHV-1400 versus placebo) in eGFR at Week 52.
Assessed by the lower limit of the 1-sided 80% confidence interval change from baseline difference
Measured: Baseline to Week 52
Number of participants experiencing any of the following during the DB phase: at least 30% reduction relative to baseline in eGFR for at least 30 days, eGFR <15 mL/min/1.73m2 for at least 30 days, chronic dialysis ≥30 days, kidney transplant, death
Measured: Up to 52 Weeks
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed through the Open-label Treatment Phase
Measured: Up to 104 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed through the Open-label Treatment Phase
Measured: 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 posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642050
- Sponsor's protocol ID
- BHV1400-301
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07642050
- Acronym / sponsor ID
- BHV1400-301
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, Chronic Kidney disease, Nephropathy, proteinuria, glomerulonephropathy, CKD, nephritis, urologic disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Jun 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.
The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-1400 | Experimental | Drug: BHV-1400500mg BHV-1400 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.
- UPCR ≥ 0.75 g/g or UPE ≥ 1.0 g/d determined via 24 hour collection.
- eGFR ≥ 30 mL/min/1.73m2 (CKD-EPI equation).
- Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.
- Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.
Key exclusion criteria (5 listed)
- Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.
- Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor/Sponsor Designee.
- Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.
- Evidence of nephrotic syndrome, defined as 24-hour protein > 3.5g with concurrent hypoalbuminemia (Albumin < 3.0 g/dl), within 6 months of Screening
- End-stage renal disease requiring dialysis or transplantation
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 |
|---|---|---|
| BHV-1400500 mg delivered subcutaneously via autoinjector | Drug | BHV-1400 |
| PlaceboMatching placebo delivered subcutaneously via autoinjector | Drug | Placebo |
Primary outcome
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52
Time frame: Baseline to Week 52
12 secondary outcomes
Change from baseline in GdIgA1 at Week 52
Time frame: Baseline to Week 52
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52
Time frame: Baseline to Week 52
Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase
Time frame: Up to 52 weeks
Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase
Time frame: Up to 52 weeks
Hematuria resolution at Week 52 (among participants with hematuria at baseline)
Time frame: Baseline to Week 52
Proportion of study participants reaching a Urinary Protein Excretion (UPE) below 0.5 g/d at Week 52
Time frame: Baseline to Week 52
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed during the DB Treatment Phase (up to 52 weeks)
Time frame: Up to 52 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed during the DB Treatment Phase (up to 52 weeks)
Time frame: Up to 52 Weeks
Change from baseline difference in the magnitude of the treatment effect (BHV-1400 versus placebo) in eGFR at Week 52.
Time frame: Baseline to Week 52
Number of participants experiencing any of the following during the DB phase: at least 30% reduction relative to baseline in eGFR for at least 30 days, eGFR <15 mL/min/1.73m2 for at least 30 days, chronic dialysis ≥30 days, kidney transplant, death
Time frame: Up to 52 Weeks
Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed through the Open-label Treatment Phase
Time frame: Up to 104 Weeks
Number of unique participants with Grade 3 to 4 lab abnormalities that are observed through the Open-label Treatment Phase
Time frame: 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 11 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BHV-1400 in people with IgA Nephropathy, run by Biohaven Therapeutics Ltd..
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 7 inclusion and 5 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 11 Jun 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. Some participants in this study may receive a placebo. 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 Chief Medical Officer (203-404-0410, clinicaltrials@biohavenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52 (time frame: Baseline to Week 52). 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 11 Jun 2026.