ADX-038 for Complement 3 Glomerulopathy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ADX-038, designed to help individuals with certain kidney diseases linked to issues in the immune system’s complement pathway. The goal is to determine if ADX-038 is safe and effective for treating complement-mediated kidney diseases such as C3 glomerulopathy (C3G) and IgA nephropathy (IgAN). Participants may qualify if a kidney biopsy has confirmed C3G or IgAN and they are already receiving supportive care for active kidney disease. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that ADX-038 is likely to be safe for humans?
Research has shown that ADX-038 is being tested to treat certain kidney diseases. Early studies have provided information about its safety. Results so far indicate that ADX-038 is generally safe for patients. Some side effects have been reported, but they are manageable and help researchers determine the right dose for future patients.
The ongoing research focuses on understanding how ADX-038 works in the body and its impact on the disease. Researchers closely monitor any side effects to ensure the treatment's safety.
For those considering joining a trial with ADX-038, safety remains a top priority. The treatment has shown promise in earlier trials, and new research aims to confirm its safety and effectiveness.12345Why do researchers think this study treatment might be promising for glomerulopathy?
Unlike the standard treatments for Complement 3 Glomerulopathy, which often include immunosuppressive therapies, ADX-038 targets the complement system directly. This new approach is exciting because ADX-038 works by specifically inhibiting the C3 protein, which plays a key role in the disease process. Researchers are hopeful that by focusing on this mechanism, ADX-038 could offer a more precise and potentially more effective treatment option, reducing the need for broad immunosuppression and its associated side effects.
What evidence suggests that ADX-038 might be an effective treatment for complement-mediated kidney diseases?
Research has shown that ADX-038 may help treat certain kidney diseases, such as C3 Glomerulopathy (C3G) and IgA Nephropathy (IgAN), which are linked to the immune system. In this trial, participants will receive different dose levels of ADX-038. One study found that a single dose of ADX-038 effectively turned off a gene called CFB, almost completely stopping a part of the immune system known as the alternative pathway. This effect lasted for up to six months. These findings suggest that ADX-038 could potentially reduce kidney damage caused by these diseases. The treatment's ability to specifically target and suppress certain immune responses makes it a promising option for patients with these conditions.12678
Who Is on the Research Team?
Aditya Patel, MD
Principal Investigator
ADARx Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
Adults with active complement-mediated kidney diseases like IgA Nephropathy or Complement 3 Glomerulopathy can join. They must have had a confirming biopsy within the past 18 (or 60 for IgAN) months, be on supportive care, meet certain kidney function levels, and follow contraception and vaccine guidelines. Pregnant or breastfeeding women cannot participate.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ADX-038 to assess safety, efficacy, pharmacokinetics, and pharmacodynamics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ADX-038
Trial Overview
The trial is testing two different doses of ADX-038 to see how safe they are and how well they work in treating kidney diseases that involve the immune system's complement system. It will also look at how the body processes the drug.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
ADARx Pharmaceuticals, Inc.
Lead Sponsor
Citations
1.
journals.lww.com
journals.lww.com/jasn/fulltext/2025/10001/interim_phase_1_study_results_of_adx_038__a_novel.2253.aspxInterim Phase 1 Study Results of ADX-038: A Novel siRNA...
A single dose of ADX-038 effectively silenced CFB gene expression, resulting in selective and near-complete suppression of complement AP activity. The durable ...
NCT06989359 | Phase 2 Study of ADX-038 in Complement ...
There are three types of expanded access: Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical ...
ADARx Pharmaceuticals Announces Clinical Data ...
Multiple Phase 2 clinical trials have been initiated to evaluate the safety and efficacy of ADX-038 in patients with complement-mediated ...
4.
finance.yahoo.com
finance.yahoo.com/news/adarx-pharmaceuticals-announces-positive-interim-160000770.htmlADARx Pharmaceuticals Announces Positive Interim ...
Single subcutaneous dose of ADX-038 achieved near-complete alternative pathway suppression for 6 months, supporting potent and selective CFB ...
5.
linkedin.com
linkedin.com/posts/adarx-pharmaceuticals-inc_kidneywk-sirna-rnatherapeutics-activity-7386025160941883392-W2DZADX-038 clinical data presented at #KidneyWk 2025 ...
Today, we announced we're presenting initial Phase 1 clinical data for ADX-038 at the American Society of Nephrology #KidneyWk 2025.
News
Multiple Phase 2 clinical trials have been initiated to evaluate the efficacy and safety of ADX-038 in patients with complement-mediated ...
ADARx Pharmaceuticals Announces Clinical Data ...
Multiple Phase 2 clinical trials have been initiated to evaluate the safety and efficacy of ADX-038 in patients with complement-mediated ...
Phase 2 Study of ADX-038 in Complement-Mediated Kidney ...
This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-038 in adults with ...
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