A Study of JADE101 in Participants With Immunoglobulin A Nephropathy
ConditionIgA Nephropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorJade Biosciences, Inc.
About this trial
This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the overall clinical characterization of JADE101 in this patient population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants 18-60 years of age, inclusive, and of local legal consenting age at the time of signing the informed consent
eGFR ≥ 30 mL/min/1.73 m2
Biopsy-confirmed primary IgAN
Receiving stable and maximally tolerated doses of either ACEi or ARB as per standard of care (SoC) and applicable guidelines for at least 12 weeks prior to the initial screening visit, with no intention to alter the dose or discontinue treatment, unless medically necessary
Disqualifiers
Secondary forms of IgAN
Known or suspected coexisting Chronic Kidney Disease (CKD) other than IgAN
Known or suspected rapidly progressive glomerulonephritis (RPGN)
Evidence of pathological findings in the kidney biopsy in addition to IgAN (eg, minimal change disease, diabetic kidney disease, membranous nephropathy, focal segmental glomerulosclerosis, or lupus nephritis); hypertensive vascular changes are acceptable
Trial design
Design model
Single group
Treatments tested in this trial
JADE101
DrugJADE101 is supplied as sterile solution to be administered by SC injection
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: JADE101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events (safety and tolerability)
The proportion of participants who experience one or more adverse events that begin or worsen after the first dose of study drug
Time frame
Day 1 through 100 weeksSecondary outcomes
1
Effect of JADE101 on Urine Protein Creatinine Ratio (UPCR) in participants with IgA nephropathy
Change from baseline in UPCR
Time frame
Day 1 through 100 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov