RecruitingPHASE2INTERVENTIONAL

A Study of the Safety and Activity of Sparsentan for the Treatment of Patients With Immunoglobulin A Nephropathy

This research study is investigating a new medication called Sparsentan for a kidney condition known as IgA Nephropathy (IgAN). The main goal is to find out if Sparsentan is a safe treatment and if it can help protect the kidneys from further damage. The study is divided into two groups: one for people who have recently been diagnosed with IgAN and haven't taken certain other kidney medications, and another group for those who have received a kidney transplant and whose IgAN has come back. Scientists want to understand how the drug affects kidney function and overall well-being, including quality of life, over a long period.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Leicester

Enrolment target

Start

10 Dec 2020

Estimated completion

31 Dec 2027

Immunoglobulin A Nephropathy Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Autoimmune Diseases Immune System Diseases

What is this study about?

This study is looking into a new medicine called Sparsentan for a specific kidney disease known as IgA Nephropathy, or IgAN. Your kidneys are vital organs that filter waste from your blood. In IgAN, a part of your immune system (your body's defence against illness) mistakenly attacks your kidneys, which can cause damage over time. This damage can lead to serious kidney problems.

The main aim of this study is to see if Sparsentan can help protect your kidneys and slow down the progression of this disease. Researchers will also be checking carefully to make sure the medicine is safe to use. The study is particularly interested in two groups of people with IgAN: those who have been recently diagnosed and haven't yet used certain common kidney medications, and those who have had a kidney transplant but whose IgAN has returned.

By taking part, you would be helping doctors and scientists understand more about IgAN and how to treat it effectively. The information gathered from this study could lead to new ways of managing this condition, potentially improving the health and quality of life for many people living with IgAN in the future.

Key takeaways

The study tests a new drug, Sparsentan, for IgA Nephropathy (a kidney disease).
It aims to see if Sparsentan is safe and protects kidneys for new diagnoses and transplant patients.
Participation involves taking daily medication and regular health checks over about two years.
Certain existing kidney medications (ACE inhibitors/ARBs) cannot be used during the study.
Your quality of life will also be monitored as part of the research.

Who may be eligible?

This study is looking for adults aged 18 or over. You might be eligible if you have recently been diagnosed with IgA Nephropathy (within the last six months) and haven't previously taken certain medications for your kidneys, like ACE inhibitors or ARBs, or haven't taken them in the last year. Your kidney biopsy must confirm you have IgAN, and specific blood and urine tests will show your current kidney function.

If you're a woman who could become pregnant, you'll need to use very reliable birth control during the study and for three months afterwards. This is to make sure you don't become pregnant while taking the study medicine.

There is also a group for people who have had a kidney transplant and whose IgAN has come back. For this group, more specific criteria will apply, including being on stable anti-rejection medication. The study will check your blood pressure to make sure it falls within a certain range.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with IgA Nephropathy by a kidney biopsy within the last six months?
Have you *not* taken specific kidney medicines (ACE inhibitors or ARBs) in the last year or ever for IgAN?
If you're a woman who could get pregnant, are you willing to use very reliable birth control during the study and for three months afterwards?
Do you have certain blood and urine test results (eGFR and protein levels) that meet the study's requirements?
Do you have blood pressure within a specific range?

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

What does participation involve?

If you join the study, you'll take the Sparsentan medicine every day. For newly diagnosed patients, you'll start with a lower dose (200 mg/day) for two weeks, then usually increase to a higher dose (400 mg/day). If the higher dose doesn't suit you, your dose might be lowered, but you'll stay on the highest dose you can manage. You'll take this medicine for just over two years (110 weeks), followed by a four-week check-up period after you stop the medicine.

During the study, you'll have regular visits where doctors will check your urine and blood tests to see how your kidneys are working. You'll also have scans like MRI to look at your kidneys and heart, and other tests to measure your body water. Your blood pressure will be monitored, and you might take other blood pressure medicines if needed, though certain types are not allowed. You'll also be asked about your quality of life to understand how you are feeling. For transplant patients, the study might involve being randomly chosen to start Sparsentan right away or after 24 weeks, while continuing your usual anti-rejection medication.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a new treatment that could help your kidney condition, and you'll receive careful medical monitoring. However, there are also potential risks, as Sparsentan is a new medicine, and side effects can occur, which will be closely watched by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

Cambridge University Hospitals NHS Trust
Cambridge, United Kingdom· Recruiting
Northern Care Alliance NHS Foundation Trust - Salford Royal
Salford, United Kingdom· Recruiting
Royal Infirmary of Edinburgh & Western General Hospital
Edinburgh, United Kingdom· Recruiting
University Hospital of wales
Cardiff, United Kingdom· Recruiting
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, United Kingdom· Recruiting
King's College Hospital
London, United Kingdom· Recruiting

Common questions

What is IgA Nephropathy?

IgA Nephropathy is a kidney disease where parts of your immune system attack and damage your kidneys, which can stop them from working properly.

What is Sparsentan?

Sparsentan is the study medicine being tested to see if it can protect kidneys from the damage caused by IgA Nephropathy.

How long will the study last?

For most participants, the main treatment period will last about 110 weeks (just over two years), with an additional four weeks of follow-up.

Will I still take my regular medicines?

You will continue most of your regular medicines, but some specific blood pressure medications (like ACE inhibitors or ARBs) are not allowed during the study.

Do I have to live in a specific area to participate?

This is a 'multi-centre' study, meaning it's happening in several locations, so you would need to be able to attend a study site for your appointments.

How to find out more

Justyna Szklarzewicz

justyna.szklarzewicz@uhl-tr.nhs.uk +44 116 258 4351 Official trial record

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