NCT06989359

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
38mo left

Started Aug 2025

Typical duration for phase_2

Geographic Reach
6 countries

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Aug 2025Jun 2029

First Submitted

Initial submission to the registry

May 22, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 28, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

May 22, 2025

Last Update Submit

April 20, 2026

Conditions

IgANC3GComplement-mediated Kidney DiseaseIgA Nephropathy (IgAN)IC-MPGN

Keywords

IgA NephropathyIgANC3GIC-MPGNcomplement-mediated kidney disease

Outcome Measures

Primary Outcomes (1)

  • Evaluate the safety and tolerability of ADX-038

    Incidence and severity of TEAEs

    Length of study - 36 months

Study Arms (3)

ADX-038 Dose Level 1 - IgAN

EXPERIMENTAL
Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 1 - C3G

EXPERIMENTAL
Drug: ADX-038 Dose Level 1

ADX-038 Dose Level 2 - IgAN

EXPERIMENTAL
Drug: ADX-038 Dose Level 2

Interventions

ADX-038 Dose Level 2DRUG

siRNA duplex oligonucleotide

ADX-038 Dose Level 2 - IgAN
ADX-038 Dose Level 1DRUG

siRNA duplex oligonucleotide

ADX-038 Dose Level 1 - C3GADX-038 Dose Level 1 - IgAN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

ADARx Clinical Site

Doral, Florida, 33122, United States

RECRUITING

ADARx Clinical Site

Miami, Florida, 33127, United States

RECRUITING

ADARx Clinical Site

Pembroke Pines, Florida, 33029, United States

RECRUITING

ADARx Clinical Site

Iowa City, Iowa, 52242, United States

RECRUITING

ADARx Clinical Site

Shreveport, Louisiana, 71101, United States

RECRUITING

ADARx Clinical Site

Shelby, Michigan, 48315, United States

RECRUITING

ADARx Clinical Site

Great Neck, New York, 11021, United States

RECRUITING

ADARx Clinical Site

Columbus, Ohio, 43210, United States

RECRUITING

ADARx Clinical Site

Dakota Dunes, South Dakota, 57049, United States

RECRUITING

ADARx Clinical Site

Dallas, Texas, 75230, United States

RECRUITING

ADARx Clinical Site

Houston, Texas, 77027, United States

RECRUITING

ADARx Clinical Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

ADARx Clinical Site

Sydney, NSW 2139, Australia

RECRUITING

ADARx Clinical Site

Woolloongabba, QLD 4102, Australia

RECRUITING

ADARx Clinical Site

Hong Kong, 2500, Hong Kong

RECRUITING

ADARx Clinical Site

Shatin, Hong Kong

RECRUITING

ADARx Clinical Site

Cheonan, 31151, South Korea

RECRUITING

ADARx Clinical Site

Daegu, 42601, South Korea

RECRUITING

ADARx Clinical Site

Gyeonggi-do, 05278, South Korea

RECRUITING

ADARx Clinical Site

Seoul, 02841, South Korea

RECRUITING

ADARx Clinical Site

Seoul, 03080, South Korea

RECRUITING

ADARx Clinical Site

Seoul, 03722, South Korea

RECRUITING

ADARx Clinical Site

Seoul, 05278, South Korea

RECRUITING

ADARx Clinical Site

Madrid, 28041, Spain

RECRUITING

ADARx Clinical Site

Newcastle upon Tyne, UK, NE7 7DN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Aditya Patel, MD

    ADARx Pharmaceuticals, Inc.

    STUDY DIRECTOR

Central Study Contacts

Lyle Gee

CONTACT

877-232-7974lgee@adarx.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 25, 2025

Study Start

August 28, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

US(11)HK(2)KR(7)AU(3)ES(1)GB(1)