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Study on the Effectiveness and Safety of RO7434656 for Patients with Primary IgA Nephropathy at High Risk of Progression

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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 kidney disease called Primary IgA Nephropathy, which is a condition where the immune system causes damage to the kidneys. The study is testing a new treatment called RO7434656, which is an antisense inhibitor of complement factor B. This treatment is designed to help reduce the progression of the disease in patients who are at high risk. The trial will compare the effects of RO7434656 with a placebo to see how well it works in reducing protein levels in the urine, which is a sign of kidney damage.

Participants in the study will receive either the RO7434656 treatment or a placebo through injections. The study will last for several weeks, during which time the participants' health and kidney function will be closely monitored. The main goal is to see if the treatment can lower the amount of protein in the urine, which is measured by the urine protein-to-creatinine ratio (UPCR). This will help determine if the treatment is effective in slowing down the disease.

Throughout the study, participants will have regular check-ups to assess their kidney function and overall health. The study will also look at other factors, such as changes in fatigue levels and any side effects that may occur. By the end of the study, researchers hope to gather enough information to understand the safety and effectiveness of RO7434656 in treating Primary IgA Nephropathy.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, participation is confirmed based on specific criteria, including a diagnosis of primary IgA nephropathy confirmed by a kidney biopsy within the last 7 years.

    Participants must have been treated with the maximum tolerated doses of certain blood pressure medications for at least 90 days before the study begins.

  2. Step 2

    Initial assessments

    Initial assessments include measuring protein levels in urine and kidney function. These assessments are done through a 24-hour urine collection and a blood test to calculate the estimated glomerular filtration rate (eGFR).

    Vaccinations against specific infections are required if not done in the last 3 years.

  3. Step 3

    Treatment phase

    Participants receive either the study medication, RO7434656, or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous).

    The frequency and dosage of the medication are determined by the study protocol and are administered regularly throughout the study period.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring of protein levels in urine and kidney function is conducted to assess the effectiveness of the treatment.

    Participants are monitored for any side effects or adverse events throughout the study.

  5. Step 5

    Final assessments

    At the end of the study period, final assessments are conducted to evaluate changes in protein levels in urine and kidney function.

    The study aims to determine the change in proteinuria at Week 37 and other outcomes at Week 105.

Who can join the trial?

6 criteria

  • The patient must have **Primary Immunoglobulin A (IgA) Nephropathy**, which is a kidney condition confirmed by a kidney biopsy done within the last 7 years or during the screening period. There should be no known secondary cause for this condition.
  • The patient should have been treated with the highest doses they can tolerate of **angiotensin-converting enzyme (ACE) inhibitors** or **angiotensin receptor blockers (ARBs)** for at least 90 days before the screening. These are medications that help manage blood pressure and protect the kidneys. Short breaks in treatment due to illness are allowed, but not for more than 7 consecutive days.
  • The patient must have a **urine protein-to-creatinine ratio (UPCR)** of at least 1 gram per gram or urine protein excretion of at least 1 gram per day, with UPCR being at least 0.8 grams per gram. This is measured from a 24-hour urine collection during screening, which should be done no more than 60 days before the first day of the study.
  • The patient should have an **estimated glomerular filtration rate (eGFR)** of at least 20 milliliters per minute per 1.73 square meters. This is a measure of how well the kidneys are filtering blood, calculated using a specific equation from 2021.
  • The patient must have been vaccinated against **Neisseria meningitidis** within the last 3 years before starting the study treatment, and also against **Streptococcus pneumoniae**. Vaccination against **Haemophilus influenzae** should be done according to national recommendations for patients receiving certain types of medications that affect the immune system.
  • Female participants must agree to use specific methods of contraception as defined by the study protocol. There are no contraception requirements for male participants.

Who cannot join the trial?

10 criteria

  • Patients who do not have **Primary Immunoglobulin A (IgA) Nephropathy**. This is a kidney condition where a protein called IgA builds up in the kidneys, causing damage.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
  • Patients who are currently participating in another clinical trial, as this could affect the results of the study.
  • Patients who have a history of drug or alcohol abuse, which might affect their ability to follow the study procedures.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who have a known allergy or reaction to the study medication or similar drugs.
  • Patients who have certain abnormal lab test results that might indicate other health issues.
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Investigated drugs

RO7434656 is an experimental medication being studied for its potential to help patients with a kidney condition called primary IgA nephropathy. This condition can lead to kidney damage over time. RO7434656 works by targeting and inhibiting a specific protein in the body known as Complement Factor B. By doing this, it aims to reduce the amount of protein that leaks into the urine, which is a sign of kidney damage. The goal of the study is to see if RO7434656 can effectively lower protein levels in the urine and help protect the kidneys from further harm.

What is already known about the treatment

RO7434656 – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating Primary Immunoglobulin A (IgA) Nephropathy, a kidney disease. It is an antisense inhibitor targeting Complement Factor B, which plays a role in the immune system's complement pathway. By inhibiting this factor, RO7434656 aims to reduce inflammation and proteinuria, which is the presence of excess protein in the urine, a common symptom of IgA Nephropathy. This medication is classified as an antisense oligonucleotide, a type of drug designed to interfere with specific genetic material to prevent disease progression.

Investigated diseases

Primary Immunoglobulin A (IgA) Nephropathy – This is a kidney disease that occurs when IgA, a protein that helps the body fight infections, builds up in the kidneys. This buildup can cause inflammation and damage to the kidney tissues. Over time, the disease can lead to the kidneys losing their ability to filter waste from the blood effectively. Symptoms may include blood in the urine, swelling in the hands and feet, and high blood pressure. The progression of the disease can vary, with some individuals experiencing slow progression while others may have a more rapid decline in kidney function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502102-32-00Protocol codeWA43966Estimated enrolment428 patientsSponsorF. Hoffmann-La Roche AG

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