NCT07054684

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
14mo left

Started Jul 2025

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

July 30, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

June 27, 2025

Last Update Submit

March 6, 2026

Conditions

IgA Nephropathy

Keywords

IgANproteinuriaglomerulonephropathychronic kidney diseasekidney diseaseCKDnephritisurologic diseaseglomerulonephritisGlomerular diseaseIga nephropathyrenal disease

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Up to 1 year

Study Arms (1)

BHV-1400

EXPERIMENTAL
Drug: BHV-1400

Interventions

BHV-1400DRUG

BHV-1400 is delivered subcutaneously (SC)

BHV-1400

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Participants must have biopsy-confirmed IgA Nephropathy

You may not qualify if:

  • Any secondary IgAN
  • Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

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-006

Chesterfield, Missouri, 63017, United States

RECRUITING

Site-002

Dakota Dunes, South Dakota, 57049, United States

RECRUITING

Site-004

Houston, Texas, 77099, United States

RECRUITING

Site-007

Leicester, LE5 4PW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuriaRenal Insufficiency, ChronicKidney DiseasesNephritisUrologic DiseasesGlomerulonephritis

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRenal InsufficiencyChronic DiseaseDisease AttributesPathologic Processes

Central Study Contacts

Chief Medical Officer

CONTACT

203-404-0410clinicaltrials@biohavenpharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

July 30, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

GB(1)US(11)