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

Phase 2

Not yet recruiting

• Conditions: IgAN; C3G; Complement-mediated Kidney Disease
• Interventions: Drug: ADX-038

• Registration Number: NCT06989359
• Lead Sponsor: ADARx Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-07
• Primary Completion: 2027-07
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active - IgAN	ADX-038	IgAN kidney disease
Active - C3G	ADX-038	C3G kidney disease

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of ADX-038	Length of study - 36 months	Incidence and severity of TEAEs