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

ADARx Pharmaceuticals

Status and phase

Enrolling

Phase 2

Conditions

IgA Nephropathy (IgAN)

IC-MPGN

C3G

Complement-mediated Kidney Disease

IgAN

Treatments

Drug: ADX-038 Dose Level 1

Drug: ADX-038 Dose Level 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT06989359

ADX-038-201

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 3 patient groups

ADX-038 Dose Level 1 - IgAN

Experimental group

Treatment:

Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 1 - C3G

Experimental group

Treatment:

Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 2 - IgAN

Experimental group

Treatment:

Drug: ADX-038 Dose Level 2

Trial contacts and locations

Central trial contact

Lisa Melia, MA

Data sourced from clinicaltrials.gov

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