IgA NephropathyPhase 1NCT07054684
Study of BHV-1400 in IgA Nephropathy
A Phase 1 study testing BHV-1400 in people with IgA Nephropathy, run by Biohaven Therapeutics Ltd. at 15 sites in 2 countries.
Trial summary
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN). Read more about this study
- Who is it for?
- Ages 18 to 65 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 30 Jul 2025to Jul 2027
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants must have biopsy-confirmed IgA Nephropathy
Who cannot join
- Any secondary IgAN
- Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Site-006
Chesterfield, Missouri, 63017
- Recruiting
Site-002
Dakota Dunes, South Dakota, 57049
- Recruiting
Site-001
Farmington, Connecticut, 06030
- Recruiting
Site-009
Hinsdale, Illinois, 60521
- Recruiting
Site-014
Houston, Texas, 77027
- Recruiting
Site-004
Houston, Texas, 77099
- Recruiting
Site-012
Indianapolis, Indiana, 46268
- Recruiting
Site-008
Lawrenceville, Georgia, 30046
- Recruiting
Site-003
Miami Lakes, Florida, 33016
- Recruiting
Site-011
Miami Lakes, Florida, 33172
- Recruiting
Site-013
Orlando, Florida, 32806
- Recruiting
Site-005
Pembroke Pines, Florida, 33029
- Recruiting
Site-016
Salt Lake City, Utah, 84115
- Recruiting
Site-015
Shelby, Michigan, 48316
United Kingdom1 site, 1 recruiting
- Recruiting
Site-007
Leicester, LE5 4PW
About this study
Official title: An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
- Conditions
- IgA Nephropathy
- Being tested
- BHV-1400
- Keywords
- IgAN, proteinuria, glomerulonephropathy, chronic kidney disease, kidney disease, CKD, nephritis, urologic disease, glomerulonephritis, Glomerular disease, Iga nephropathy, renal disease
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria, Renal Insufficiency, Chronic, Kidney Diseases, 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
BHV-1400 is delivered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| BHV-1400 | Experimental | Not described Receives: Drug: BHV-1400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths
Measured: Up to 1 year
Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start30 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07054684
- Sponsor's protocol ID
- BHV1400-102
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2025
- Last updated
- 23 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Biomarker Study of BHV-1400 in IgA Nephropathy
- ClinicalTrials.gov ID
- NCT07054684
- Acronym / sponsor ID
- BHV1400-102
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, proteinuria, glomerulonephropathy, chronic kidney disease, kidney disease, CKD, nephritis, urologic disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 8 Jul 2025 (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 a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHV-1400 | Experimental | Drug: BHV-1400 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants must have biopsy-confirmed IgA Nephropathy
Key exclusion criteria (2 listed)
- Any secondary IgAN
- Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
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-1400BHV-1400 is delivered subcutaneously (SC) | Drug | BHV-1400 |
Primary outcome
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
Time frame: Up to 1 year
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths
Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities
Time frame: Up to 1 year
To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
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 23 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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-1400 in people with IgA Nephropathy, run by Biohaven Therapeutics Ltd. at 15 sites in 2 countries.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 23 Jun 2026.