Not recruitingRare disease

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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as complement-mediated renal disease, which affects the kidneys. The trial will explore the effects of a new treatment called ARO-C3, which is a solution for injection. ARO-C3 contains an active substance known as ADS-011, a type of synthetic, double-stranded, small interfering RNA (siRNA) that is designed to target specific processes in the body. The study aims to understand how safe and tolerable ARO-C3 is for patients, as well as how it behaves in the body over time.

The trial will involve adult participants, including both healthy volunteers and those with complement-mediated renal disease. Participants will receive multiple doses of ARO-C3 through subcutaneous injection, which means the injection is given under the skin. The study will monitor participants for any side effects and measure how the drug is processed by the body. Additionally, researchers will observe changes in certain proteins in the blood that are related to the disease.

The purpose of this study is to gather important information about ARO-C3, which could potentially lead to new treatment options for people with complement-mediated renal disease. The trial will take place over a period of time, with participants attending scheduled visits to receive the treatment and undergo various assessments. This research is an important step in understanding how ARO-C3 can help manage this kidney condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A negative COVID-19 test or proof of vaccination is required. Vaccinations for certain diseases may also be necessary if not already completed.
Step 2
Baseline evaluation
A baseline evaluation is performed to establish initial health metrics. This includes blood tests and other assessments to measure kidney function and protein levels in urine.
Step 3
Administration of ARO-C3
The medication ARO-C3 is administered as a subcutaneous injection. The dosage and frequency are determined based on the study protocol and individual health status.
The treatment aims to evaluate the safety and effects of the medication on kidney function and related health parameters.
Step 4
Monitoring and follow-up
Regular follow-up visits are scheduled to monitor health and any potential side effects. Blood tests and other assessments are conducted to track changes in kidney function and protein levels.
The study continues until the estimated end date, with ongoing evaluations to ensure safety and effectiveness.
Step 5
Completion of study
Upon completion of the study, a final assessment is conducted to evaluate overall health and the impact of the treatment.
Participants are advised on any necessary follow-up care or additional treatments based on the study findings.

Who can join the trial?

13 criteria

Able and willing to provide written informed consent before any study-specific procedures.
If you can have children, you must agree to use highly effective birth control and a condom during the study and for at least 90 days after the study ends or after the last dose of the study drug, whichever is later. You must not donate sperm or eggs during this time.
Willing and able to attend all study visits and meet all study requirements.
No abnormal findings during the initial health check that could affect your safety or the study results, according to the study doctor.
For certain groups, a kidney biopsy confirming specific kidney conditions within the last 3 to 5 years is required.
Ongoing kidney disease with significant protein in the urine, confirmed by tests during the screening period.
Kidney function must be at a certain level, calculated by a specific method, and you should not be on dialysis.
Your kidney disease must be stable or getting worse, and you should be on a stable treatment plan for at least 90 days before the first dose of the study drug. This treatment may include medications like immunosuppressants, blood pressure medications, or drugs that reduce protein in the urine.
You must have been on a recommended dose of certain blood pressure medications for at least 90 days before the first dose of the study drug, unless you cannot take them due to intolerance or allergy.
Vaccinated for certain bacteria within the past 2 years or willing to receive vaccinations before and during the study. If you do not respond to these vaccines, you may be exempted from this requirement.
A negative COVID-19 test result during the screening period or proof of vaccination with available COVID-19 vaccines.
Male or non-pregnant, non-breastfeeding female volunteers aged 18 to 70 years.
Body mass index (BMI) between 18.0 and 35.0 kg/m². If your BMI is outside this range, you may still be allowed to participate at the study doctor's discretion.

Who cannot join the trial?

10 criteria

Patients who have any other serious health condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of allergic reactions to similar medications.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have an infection that requires treatment with antibiotics.
Patients who have a condition that affects their immune system, making them more prone to infections.
Patients who have a history of cancer, except for certain types of skin cancer.

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Verified sites

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Universitaetsklinikum Erlangen AöR
Erlangen, Germany
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University Hospital Cologne
Cologne, Germany

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Investigated drugs

ARO-C3 is a medication being studied to understand its safety and how well it is tolerated by the body. It is being tested in adults who have kidney diseases caused by problems with the complement system, which is part of the immune system. The study aims to see how the body processes ARO-C3 and how it affects the body, especially in terms of its impact on kidney disease.

Ads-011

What is already known about the treatment

ARO-C3 – ARO-C3 is administered through injection and is currently being studied in clinical trials to assess its safety and effectiveness. It is primarily being investigated for the treatment of complement-mediated renal disease. The medication works by targeting specific components of the complement system, which is part of the immune system, to reduce inflammation and damage in the kidneys. ARO-C3 is classified as an investigational drug, and its use is still under evaluation in medical research.

Investigated diseases

Complement-mediated renal disease – This is a group of disorders where the immune system's complement pathway, which helps clear pathogens, becomes overactive and attacks the kidneys. This overactivity can lead to inflammation and damage to the kidney tissues. Over time, the damage can impair the kidneys' ability to filter waste from the blood. Symptoms may include blood in the urine, protein in the urine, and high blood pressure. The progression of the disease can vary, with some individuals experiencing rapid deterioration of kidney function, while others may have a slower progression. The exact cause of the complement system's overactivity in these diseases is not fully understood.