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

NCT ID: NCT06989359

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2028-07-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADX-038 Dose Level 1 - IgAN

Group Type EXPERIMENTAL

ADX-038 Dose Level 1

Intervention Type DRUG

siRNA duplex oligonucleotide

ADX-038 Dose Level 1 - C3G

Group Type EXPERIMENTAL

ADX-038 Dose Level 1

Intervention Type DRUG

siRNA duplex oligonucleotide

ADX-038 Dose Level 2 - IgAN

Group Type EXPERIMENTAL

ADX-038 Dose Level 2

Intervention Type DRUG

siRNA duplex oligonucleotide

Interventions

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ADX-038 Dose Level 2

siRNA duplex oligonucleotide

Intervention Type DRUG

ADX-038 Dose Level 1

siRNA duplex oligonucleotide

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADARx Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aditya Patel, MD

Role: STUDY_DIRECTOR

ADARx Pharmaceuticals, Inc.

Locations

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ADARx Clinical Site

Shreveport, Louisiana, United States

Site Status RECRUITING

ADARx Clinical Site

Shelby, Michigan, United States

Site Status RECRUITING

ADARx Clinical Site

Dakota Dunes, South Dakota, United States

Site Status RECRUITING

ADARx Clinical Site

Dallas, Texas, United States

Site Status RECRUITING

ADARx Clinical Site

Houston, Texas, United States

Site Status RECRUITING

ADARx Clinical Site

Wollongong, New South Wales, Australia

Site Status RECRUITING

ADARx Clinical Site

Pok Fu Lam, , Hong Kong

Site Status RECRUITING

ADARx Clinical Site

Shatin, , Hong Kong

Site Status RECRUITING

ADARx Clinical Site

Gyeonggi-do, New South Wales, South Korea

Site Status RECRUITING

ADARx Clinical Site

Seoul, New South Wales, South Korea

Site Status RECRUITING

ADARx Clinical Site

Cheonan, , South Korea

Site Status RECRUITING

ADARx Clinical Site

Seoul, , South Korea

Site Status RECRUITING

Countries

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United States Australia Hong Kong South Korea

Central Contacts

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Lisa Melia, MA

Role: CONTACT

877-232-7974

Other Identifiers

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ADX-038-201

Identifier Type: -

Identifier Source: org_study_id

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