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A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy

ConditionIgA Nephropathy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBiohaven Therapeutics Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • BHV-1400

    Drug

    500 mg delivered subcutaneously via autoinjector

  • Placebo

    Drug

    Matching placebo delivered subcutaneously via autoinjector

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: BHV-1400Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52

Time frame
Baseline to Week 52

Secondary outcomes

1

Change from baseline in GdIgA1 at Week 52

Time frame
Baseline to Week 52
2

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52

Time frame
Baseline to Week 52
3

Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase

Time frame
Up to 52 weeks
4

Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase

Time frame
Up to 52 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biohaven Therapeutics Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: