A Phase 3 interventional study of BHV-1400 and Placebo in IgA Nephropathy, sponsored by Biohaven Therapeutics Ltd.. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Biohaven Therapeutics Ltd. · Phase 3, Interventional, and Treatment
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.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 420 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →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.
Key Inclusion Criteria:
Diagnosis of IgAN as confirmed by renal conducted within 10 years prior to Screening.
Key Exclusion Criteria:
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
500mg BHV-1400 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
Drug: BHV-1400
Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.
Drug: Placebo
500 mg delivered subcutaneously via autoinjector
Matching placebo delivered subcutaneously via autoinjector
Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52
Time frame: Baseline to Week 52
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.
Assessed by the lower limit of the 1-sided 80% confidence interval change from baseline difference
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
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Sep 2028, 27 months later.
Of 26 phase 3 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 70. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Biohaven Therapeutics Ltd.