ClinicalTrials.gg
RecruitingNCT07054684Updated Jun 23, 2026

Study of BHV-1400 in IgA Nephropathy

A Phase 1 interventional study of BHV-1400 in IgA Nephropathy, sponsored by Biohaven Therapeutics Ltd.. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Biohaven Therapeutics Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).

02

Conditions studied

  • IgA Nephropathy

Keywords

  • IgAN
  • proteinuria
  • glomerulonephropathy
  • chronic kidney disease
  • kidney disease
  • CKD
  • nephritis
  • urologic disease
  • glomerulonephritis
  • Glomerular disease
  • Iga nephropathy
  • renal disease
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 20 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

1. Participants must have -confirmed IgA Nephropathy

Key Exclusion Criteria:

  1. Any secondary IgAN
  2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    BHV-1400

    Drug: BHV-1400

Interventions

  • DrugBHV-1400

    BHV-1400 is delivered subcutaneously (SC)

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 1 year

  2. 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.

    Time frame: Up to 1 year

07

Study locations

15 of 15 sites recruiting
  • Site-001
    Farmington, Connecticut 06030, United States
    Recruiting
  • Site-003
    Miami Lakes, Florida 33016, United States
    Recruiting
  • Site-011
    Miami Lakes, Florida 33172, United States
    Recruiting
  • Site-013
    Orlando, Florida 32806, United States
    Recruiting
  • Site-005
    Pembroke Pines, Florida 33029, United States
    Recruiting
  • Site-008
    Lawrenceville, Georgia 30046, United States
    Recruiting
  • Site-009
    Hinsdale, Illinois 60521, United States
    Recruiting
  • Site-012
    Indianapolis, Indiana 46268, United States
    Recruiting
  • Site-015
    Shelby, Michigan 48316, United States
    Recruiting
  • Site-006
    Chesterfield, Missouri 63017, United States
    Recruiting
  • Site-002
    Dakota Dunes, South Dakota 57049, United States
    Recruiting
  • Site-014
    Houston, Texas 77027, United States
    Recruiting
  • Site-004
    Houston, Texas 77099, United States
    Recruiting
  • Site-016
    Salt Lake City, Utah 84115, United States
    Recruiting
  • Site-007
    Leicester, LE5 4PW, United Kingdom
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.

Of 22 phase 1 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 24 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2025
First posted
Jul 8, 2025
StartActual
Jul 30, 2025
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Jun 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07054684
Lead sponsor
Biohaven Therapeutics Ltd.
Responsible party
Sponsor
First posted
Jul 8, 2025
Start date
Jul 30, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Chief Medical Officer
Contact
clinicaltrials@biohavenpharma.com
203-404-0410

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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