RecruitingNot ApplicableObservational

Real-world experience of patients with IgA nephropathy treated with sparsentan through an Early Access Program in the UK

Immunoglobulin A (IgA) nephropathy is a condition where immune proteins build up in the kidneys, causing inflammation and protein to leak into the urine. A medicine called sparsentan was offered to some UK patients through an Early Access Program before becoming routinely available on the NHS. While clinical trials showed sparsentan can lower protein levels in urine, doctors want to see how well it works in everyday clinical practice. This study reviews health records from adults who received sparsentan through the early access scheme. Because researchers only look at existing medical notes, taking part involves no extra hospital visits, blood tests, or changes to your treatment. The findings will help doctors understand how sparsentan performs in everyday life and improve care for future kidney patients.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Vifor International AG

Enrolment target

Start

24 Aug 2026

Estimated completion

28 Feb 2027

Immunoglobulin A (IgA) nephropathy

What is this study about?

IgA nephropathy is an illness where antibodies—proteins that normally help fight off infections—settle in the kidneys by mistake. This causes swelling and damage to the tiny filters inside the kidneys. Over time, it can cause protein to leak into the urine and may slowly reduce how well the kidneys work. For some people, this can eventually lead to kidney failure.

Sparsentan is a medicine designed to protect the kidneys by reducing the amount of protein leaking into the urine. Before it became widely available on the NHS, some patients in the UK were able to receive it early through a special Early Access Program. Although formal clinical trials showed that sparsentan is effective, doctors also need to understand how it works for patients in everyday NHS clinics.

This study, led by University Hospitals of Leicester NHS Trust, brings together routine health data from hospitals across the UK. Researchers will look back at medical records to see how patients responded to sparsentan, checking measurements such as kidney function and blood pressure. The goal is to build a clearer picture of real-world outcomes to help guide future kidney treatments.

Key takeaways

Looks at real-world NHS results for the kidney medicine sparsentan.
Only includes people who received sparsentan through the UK Early Access Program.
Uses existing medical records, so no extra visits or tests are needed.
Your privacy is protected by removing personal details from the data.
You can opt out at any time without any change to your NHS care.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with primary IgA nephropathy and received sparsentan through the UK Early Access Program.

You cannot take part if you did not receive sparsentan through this specific early access scheme. You will also be excluded if you have previously registered with the NHS National Data Opt-Out service, or if you return the study opt-out letter stating you do not want your medical notes to be included.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or older?
Have you been diagnosed with primary IgA nephropathy?
Did you receive sparsentan through the UK Early Access Program?
Are you happy for your routine health notes to be reviewed for research?

Answer every question to see your result.

What does participation involve?

Taking part does not require any extra effort from you. There are no clinic appointments, tests, pills, or procedures to complete for the study. Researchers will simply review the medical records your doctors already keep, starting from when you first began sparsentan until you stopped taking it or until the study review period ends. The research runs from August 2026 to March 2027.

Potential risks and benefits

There are no physical risks or side effects from taking part because the study only looks at information already stored in your hospital notes. The main consideration is protecting your privacy. To keep your information safe, your personal details (such as your name and address) are removed and replaced with a code before being reviewed. You will not receive any direct medical benefit, but your information could help improve care for future patients. You have the right to opt out at any time without your regular NHS care being affected.

Locations (7)

University Hospitals of Leicester NHS Trust
City only
Leicester, England
Guy's and St Thomas' NHS Foundation Trust
City only
London, England
Barts Health NHS Trust
City only
London, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
NHS Lothian
Approximate
Edinburgh, Scotland
Northern Care Alliance NHS Foundation Trust
Unverified
Salford, England
Lancashire Teaching Hospitals NHS Foundation Trust
Unverified
Preston, England

Common questions

Will I need to go to hospital for extra appointments?

No. The study only looks at your existing hospital records, so you will not need any extra visits or blood tests.

Will my kidney medication change?

No. This study does not change your treatment. Your doctors will continue to manage your care as usual.

What is an Early Access Program?

It is a scheme that allows patients with serious conditions to receive promising new medicines before they become routinely available on the NHS.

How is my personal information protected?

Your records are pseudonymised, meaning details like your name are replaced with a code so researchers cannot directly identify you.

Can I choose not to take part?

Yes. If you receive an opt-out letter, you can reply stating you do not want your records included. This will not affect your medical care in any way.

How to find out more

Daniel Stevens

daniel.stevens@bionicalemas.com +44 (0)1462 414372 Official trial record

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