Chinese Adults With Kidney Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorADARx Pharmaceuticals, Inc.
About this trial
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mean eGFR greater than or equal to 30 mL/min/1.73m2
Clinical evidence of active kidney disease
Treated with supportive care including an ACE inhibitor or ARB if applicable
Willing to receive required vaccinations
Disqualifiers
Previous kidney transplant or major solid organ transplant
Required renal replacement therapy for more than 72 hours
Rapidly progressive glomerular nephritis or acute kidney injury
History of recurrent invasive infection
Trial design
Design model
Parallel
Treatments tested in this trial
ADX-038
DrugsiRNA duplex oligonucleotide
Telitacicept
Drugfusion protein
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Part A - ADX-038 MonotherapyExperimental treatment 1 intervention
Group B: Part B - ADX-038 Combination TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
Time frame
Part A - 24 Months and Part B - 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov