Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorADARx Pharmaceuticals, Inc.
About this trial
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.
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
Hereditary or acquired complement deficiency
Kidney transplant or renal replacement therapy
History of solid organ transplant
Other kidney disease
Trial design
Design model
Parallel
Treatments tested in this trial
ADX-038 Dose Level 2
DrugsiRNA duplex oligonucleotide
ADX-038 Dose Level 1
DrugsiRNA duplex oligonucleotide
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: ADX-038 Dose Level 1 - IgANExperimental treatment 1 intervention
Group B: ADX-038 Dose Level 1 - C3GExperimental treatment 1 intervention
Group C: ADX-038 Dose Level 2 - IgANExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the safety and tolerability of ADX-038
Incidence and severity of TEAEs
Time frame
Length of study - 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov