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Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

NCT06989359

RecruitingPhase 2

Sponsor: ADARx Pharmaceuticals, Inc.

Conditions: IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN), IC-MPGN

Interventions: ADX-038 Dose Level 2, ADX-038 Dose Level 1

Countries: United States, Australia, Hong Kong, Italy, South Korea, Spain, Taiwan, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (34)
  • Doral, Florida, United States
  • Miami, Florida, United States
  • Pembroke Pines, Florida, United States
  • Iowa City, Iowa, United States
  • Shreveport, Louisiana, United States
  • Shelby, Michigan, United States
  • Great Neck, New York, United States
  • Columbus, Ohio, United States
  • Dakota Dunes, South Dakota, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States
  • Liverpool, New South Wales, Australia
  • Wollongong, New South Wales, Australia
  • Sydney, Australia
  • Woolloongabba, Australia
  • Hong Kong, Hong Kong
  • Shatin, Hong Kong
  • Bergamo, Italy
  • Pavia, Italy
  • Wŏnju, Gangwon-do, South Korea
  • Gyeonggi-do, Gurogu, South Korea
  • Seoul, Gurogu, South Korea
  • Cheonan, South Korea
  • Daegu, South Korea
  • Gyeonggi-do, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Barcelona, Spain
  • + 4 more on CT.gov