Study of BHV-1400 in IgA Nephropathy
ConditionIgA Nephropathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiohaven Therapeutics Ltd.
About this trial
The purpose of this study is to determine if BHV-1400 is a safe and tolerable treatment in participants with IgA Nephropathy (IgAN).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Any secondary IgAN
Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause
Trial design
Design model
Single group
Treatments tested in this trial
BHV-1400
DrugBHV-1400 is delivered subcutaneously (SC)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: BHV-1400Experimental treatment 1 intervention
Trial outcomes
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 year2
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov