RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

This study is looking into a new treatment called sefaxersen for a kidney condition called IgA nephropathy (IgAN). IgAN can sometimes lead to serious kidney problems. The main goal is to find out if sefaxersen is safe and effective in slowing down the progression of kidney disease in people who are at a higher risk of their condition worsening, even with their usual care. Half the participants will receive the new medicine, and the other half will receive a dummy treatment (placebo). This helps us compare the effects properly. We hope the study will lead to better ways to manage IgAN and protect kidney health.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

428

Start

08 Aug 2023

Estimated completion

31 Mar 2029

Primary IgA Nephropathy

What is this study about?

This study is about an important kidney condition called IgA nephropathy (IgAN). In IgAN, tiny filters in your kidneys become inflamed, which can sometimes lead to lasting kidney damage. For some people, this damage can get worse over time, even if they are already receiving the best standard care available.

We are investigating a new medicine called sefaxersen (RO7434656). This medicine is designed to work in a specific way to try and protect the kidneys. The main purpose of this study is to see if sefaxersen can effectively slow down or stop the progression of kidney disease in people with IgAN who are at a higher risk of their condition worsening. We also want to make sure it is safe to use.

By carefully comparing sefaxersen to a placebo (a dummy treatment), we can understand if this new medicine truly makes a difference. The results of this study could help us find new and better ways to treat IgAN and improve the long-term health of people living with this condition.

Key takeaways

This study evaluates sefaxersen, a new medicine for IgA nephropathy.
It aims to slow down kidney disease in high-risk patients.
Participation involves receiving either the new medicine or a placebo.
Regular health checks and blood/urine tests will monitor your health.
Your IgA nephropathy must be confirmed by a recent kidney biopsy.
This research could lead to improved treatments for IgA nephropathy.

Who may be eligible?

To join this study, your doctor would need to confirm you have IgA nephropathy, based on a kidney biopsy done in the last 10 years. You also need to be taking certain blood pressure medications (like ACE inhibitors or ARBs) at their highest tolerated dose for at least 3 months, and your doctor shouldn't plan to change these during the study. Your kidney function, measured by your eGFR, needs to be 20 mL/min/1.73 m² or higher, and you should have a certain level of protein in your urine (at least 1 gram per day).

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or plan to become pregnant soon after the study. You also wouldn't be eligible if you have another serious autoimmune kidney disease, or if your kidney disease is worsening very quickly. A history of a kidney transplant, diabetes, or uncontrolled high blood pressure would also mean you couldn't take part. You also shouldn't have recently started certain other kidney medications.

Quick self-check

I have been diagnosed with IgA nephropathy by a kidney biopsy in the last 10 years.
I am currently taking specific blood pressure medicines (ACE inhibitors or ARBs) at my highest comfortable dose.
My kidney function (eGFR) is 20 mL/min/1.73 m² or higher.
I have protein in my urine, more than 1 gram per day.
I am not pregnant or breastfeeding, and don't plan to be during or shortly after the study.
I do not have diabetes or very high blood pressure that isn't controlled.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would either receive the new medicine, sefaxersen, or a placebo (a dummy treatment without active medicine) – it's decided randomly, like flipping a coin. You wouldn't know which you are getting, and neither would your study doctor. Over several appointments, we would regularly check your kidney function, blood pressure, and other health markers through blood and urine tests. You would also have physical examinations. The exact number of visits and the duration of the study would be fully explained by the study team, but it will involve regular follow-up over an extended period. All study-related medication and assessments would be provided at no cost.

Potential risks and benefits

Taking part in this study could offer you access to a new potential treatment for IgA nephropathy before it's widely available. It also contributes to medical research that could help many others with the same condition in the future. However, there's no guarantee the treatment will work for you, and like all medicines, sefaxersen could have side effects. These would be fully explained by the study team. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (204)

Alabama Kidney Research - ERN - PPDS
Alabaster, United States· Recruiting
UAB Nephrology Research Clinic
Birmingham, United States· Recruiting
Sunrise Medical Management LLC
Surprise, United States· Withdrawn
Tucson Neuroscience Research - M3 WR
Tucson, United States· Withdrawn
Kidney Disease Medical Group Inc-1505 Wilson Ter
Glendale, United States· Recruiting
Southern California Medical Research Center
La Palma, United States· Withdrawn
Academic Medical Research Institute - Los Angeles
Los Angeles, United States· Recruiting
University of California, Los Angeles (UCLA) - Hematology/Oncology Santa Monica
Los Angeles, United States· Recruiting
Los Angeles County Nephrology
Montebello, United States· Recruiting
North America Research Institute-San Dimas
San Dimas, United States· Recruiting
Kaiser Permanente Skyport Medical Offices
San Jose, United States· Recruiting
BioResearch Partner ? Jackson West
Doral, United States· Recruiting

+192 more sites — see the official record for the full list.

Common questions

What is IgA nephropathy?

IgA nephropathy is a kidney disease where a specific antibody (IgA) builds up in your kidneys, causing inflammation and sometimes kidney damage.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps us see if the new medicine is truly effective compared to receiving no active treatment.

Will I know if I'm getting the active drug or the placebo?

No, neither you nor the study doctors will know whether you are receiving sefaxersen or the placebo during the main part of the study. This helps keep the results unbiased.

What does a kidney biopsy involve?

A kidney biopsy is a procedure where a small piece of kidney tissue is removed and examined under a microscope to confirm kidney conditions like IgA nephropathy.

Can I still take my regular medications during the study?

Most of your regular medications, especially those for blood pressure like ACE inhibitors or ARBs, will need to be continued as prescribed. The study team will review all your medications.

How to find out more

WA43966 https://forpatients.roche.com/

global-roche-genentech-trials@gene.com 888-662-6728 (U.S. Only) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.