C3G, Complement-mediated Kidney Disease, IC-MPGN, IgAN, IgA Nephropathy (IgAN)
Conditions
Keywords
IgA Nephropathy, IgAN, C3G, IC-MPGN, complement-mediated kidney disease
Brief summary
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.
Interventions
DRUGADX-038 Dose Level 2
siRNA duplex oligonucleotide
DRUGADX-038 Dose Level 1
siRNA duplex oligonucleotide
Sponsors
ADARx Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy
Exclusion criteria
* Hereditary or acquired complement deficiency * Kidney transplant or renal replacement therapy * History of solid organ transplant * Other kidney disease * History of recurrent invasive infections * Received complement inhibitor treatments * Active systemic viral, bacterial, or fungal infection * Abnormal liver function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the safety and tolerability of ADX-038 | Length of study - 36 months | Incidence and severity of TEAEs |
Countries
Australia, Hong Kong, Italy, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTTracy Nguyen
STUDY_DIRECTORArezoo Mirad, MD
ADARx Pharmaceuticals, Inc.
Outcome results
None listed