Immune-mediated renal disorder Trials in Disease

Study on the Safety and Effects of ARO-C3 for Adults with Complement-Mediated Kidney Disease

This clinical trial is investigating ARO-C3, a new medication for treating kidney disease caused by an overactive complement system. The complement system is part of the immune system that normally helps clear harmful pathogens, but when it becomes overactive, it can attack the kidneys and cause inflammation and damage.

Main inclusion criteria:

• Adults aged 18 to 70 years who are able to provide written informed consent
• Confirmed kidney disease with significant protein in the urine, demonstrated by tests during screening
• A kidney biopsy confirming specific kidney conditions within the last 3 to 5 years (for certain groups)
• Kidney function at a certain level and not requiring dialysis
• Stable or worsening kidney disease, with a stable treatment plan for at least 90 days before receiving the study drug
• Vaccination for certain bacteria within the past 2 years or willingness to receive vaccinations
• Negative COVID-19 test or proof of COVID-19 vaccination
• Body mass index between 18.0 and 35.0 kg/m²
• Willingness to use effective birth control during the study and for at least 90 days after

Main exclusion criteria:

• Any other serious health condition that might interfere with the study
• Currently participating in another clinical trial
• Recent major surgery or planned surgery during the study period
• Pregnancy or breastfeeding
• History of allergic reactions to similar medications
• History of drug or alcohol abuse
• Active infection requiring antibiotic treatment
• Condition affecting the immune system that increases infection risk
• History of cancer, except for certain types of skin cancer
• Unable to follow study procedures or attend required visits

Focus and goal of the trial:

The primary aim of this study is to evaluate the safety and tolerability of ARO-C3 in adults with complement-mediated kidney disease. Researchers will monitor how the body processes the medication and observe its effects on kidney function and disease-related proteins in the blood. The trial involves multiple doses of ARO-C3 administered through subcutaneous injection, which means the medication is injected under the skin. Participants will attend scheduled visits for treatment administration and various assessments, including blood tests to monitor kidney function and protein levels in urine. This research represents an important step toward understanding whether ARO-C3 could become a new treatment option for managing this type of kidney condition.

Investigational drug:

ARO-C3 is the medication being tested in this trial. It contains an active substance called ADS-011, which is a type of synthetic, double-stranded, small interfering RNA (siRNA). This investigational drug is designed to target specific components of the complement system to reduce inflammation and damage in the kidneys. ARO-C3 is administered as a solution for injection under the skin, and researchers are evaluating both its safety profile and its potential effectiveness in treating complement-mediated kidney disease.

Summary

There is currently one active clinical trial for immune-mediated renal disorder, taking place in Germany. This trial focuses exclusively on ARO-C3, an innovative investigational medication that uses RNA-based technology to target the complement system. The study is designed to gather important safety and tolerability data while also observing the medication's effects on kidney function and disease markers. This trial represents an emerging approach to treating kidney diseases caused by immune system dysfunction, specifically targeting the complement pathway that becomes overactive in these conditions. Patients interested in this trial should note that it requires stable kidney disease with certain function levels, prior vaccination requirements, and a commitment to attending regular monitoring visits throughout the study period.