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

Launched by ADARX PHARMACEUTICALS, INC. · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial, called a Phase 2 study, is looking at a new treatment called ADX-038 for adults with certain kidney diseases caused by the complement system, which is part of the immune system. The trial aims to learn how safe ADX-038 is, how well it works, and how it moves through the body. It will include people aged 65 to 74 who have active kidney disease and have been receiving supportive care. Eligible participants must have a confirmed diagnosis of either IgA nephropathy (IgAN) or complement 3 glomerulopathy (C3G) based on kidney biopsies done within specific time frames.

Participants in this trial can expect close monitoring of their health and responses to the treatment. It's important to note that the trial is not currently recruiting, and it has certain criteria that must be met to join. For example, women cannot be pregnant or breastfeeding, and men must agree to use contraception. Additionally, individuals with certain health conditions, like a history of kidney transplants or other serious infections, will not be eligible to participate. This trial represents a potential step forward in finding new treatments for these kidney diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Mean eGFR
• • Clinical evidence of active kidney disease
• • Been on supportive care
• • vaccine requirements
• • Females must not be pregnant or breastfeeding
• • Men must agree to use acceptable contraception and not donate sperm
• • IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening
• • C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening
• 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
• • Liver dysfunction
• • No donating blood