Actively Recruiting
A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-06-08
30
Participants Needed
10
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ADX-038 in a Phase 2 trial involving Chinese adults who have complement-mediated kidney diseases, including Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study aims to evaluate the safety, efficacy, and how the body processes ADX-038 alone and combined with another drug, telitacicept. This research helps understand potential new treatments for these kidney conditions. The trial consists of two parts: Part A tests ADX-038 alone, and Part B tests it in combination with telitacicept. Both treatments are experimental drugs being studied for their effects on the diseases. ADX-038 is a small interfering RNA duplex oligonucleotide, while telitacicept is a fusion protein. Participants will receive the study treatments and be closely monitored throughout the study periods. Participants will be involved in regular assessments to monitor safety and tolerability for up to 24 months in Part A and 15 months in Part B. The research team will evaluate kidney function and other health measures, ensuring patients receive vaccinations as required. The study excludes those with previous major organ transplants, certain infections, or abnormal liver function. This involvement helps researchers learn about how these drugs work in people with specific kidney diseases.
CONDITIONS
Brief Title
Chinese Adults With Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Previous kidney transplant or major solid organ transplant
- Required renal replacement therapy for more than 72 hours
- Rapidly progressive glomerular nephritis or acute kidney injury
- History of recurrent invasive infection
- Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
- Active TB, HIV or other systemic infection
- Abnormal liver function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Part A - 24 months; Part B - 15 months
Participants receive ADX-038 as monotherapy or in combination with telitacicept to treat complement-mediated kidney disease.
Trial Site Locations
Total: 10 locations
1
ADARx Clinical Site
Shenzhen, Guangdong, China, 518100
Actively Recruiting
2
ADARx Clinical Site
Guiyang, Guizhou, China
Actively Recruiting
3
ADARx Clinical Site
Zhengzhou, Henan, China
Not Yet Recruiting
4
ADARx Clinical Site
Baotou, Inner Mongolia, China, 014000
Actively Recruiting
5
ADARx Clinical Site
Wuxi, Jiangsu, China, 214000
Actively Recruiting
6
ADARx Clinical Site
Yantai, Shandong, China, 264008
Actively Recruiting
7
ADARx Clinical Site
Beijing, China, 100034
Actively Recruiting
8
ADARx Clinical Site
Shandong, China
Not Yet Recruiting
9
ADARx Clinical Site
Shanghai, China
Actively Recruiting
10
ADARx Clinical Site
Shangxi, China
Not Yet Recruiting
Research Team
S
Stephanie Leyva
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here