RecruitingPHASE1, PHASE2INTERVENTIONAL

PS-002 for the Treatment of IgA Nephropathy in Adults

This research is testing a new medication called PS-002 for adults who have a kidney condition called IgA nephropathy. This is an early phase (Phase 1/2) study, meaning it's one of the first times this treatment is being given to people. The main goals are to check if PS-002 is safe to use, how well people tolerate it, and if it shows any early signs of helping the condition. Participants joining this study will typically be adults whose IgA nephropathy is considered at a higher risk of getting worse, even though they are already receiving standard care. The study involves monitoring participants for up to a year after they receive PS-002, with an option for longer-term follow-up for a total of five years.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Purespring Therapeutics Limited

Enrolment target

Start

01 Feb 2026

Estimated completion

01 Sep 2029

Immunoglobulin A (IgA) Nephropathy

What is this study about?

This study is about a kidney condition called IgA nephropathy. In this condition, a type of protein called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation and damage over time. This can affect how well your kidneys filter waste from your blood.

The study is testing a new medication, PS-002. This is what's called a 'first-in-human' study, which means it’s one of the first times this particular treatment is being given to people. The researchers want to find out if PS-002 is safe and if people can take it without too many unwanted side effects. They also want to see if the treatment shows any early signs of being helpful for IgA nephropathy.

Participants in this study will be adults living with IgA nephropathy who are at a higher risk of their kidney disease getting worse, even though they are already receiving the usual care for their condition. The aim is to see if PS-002 could offer a new way to help manage this condition.

Key takeaways

This is an early-stage study (Phase 1/2) testing a new drug, PS-002, for IgA nephropathy.
The main goals are to check for safety, how well people tolerate it, and early signs of effectiveness.
Participants are adults with IgA nephropathy at high risk of progression, already on standard care.
The study involves close monitoring for up to one year, with an optional 5-year follow-up.
Your participation may not directly benefit you but could help advance treatments for IgA nephropathy.
You have the right to withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult diagnosed with IgA nephropathy, confirmed by a kidney biopsy. This biopsy should show certain signs of ongoing activity in your kidney. Your kidney function, measured by something called eGFR, also needs to be above a certain level, and your blood pressure should be within specific limits. You should also be receiving the standard care for IgA nephropathy as recommended by your doctor.

There are also reasons why you might not be able to join. For example, if you have a severe form of kidney protein loss called nephrotic syndrome, or if your IgA nephropathy is related to another health condition like certain autoimmune diseases, liver problems, or cancers. Also, if you've had a history of cancer, an organ transplant, or certain immune system problems like HIV, you wouldn't be able to participate. The study is very specific about who can take part to ensure safety and that the results are clear.

The research team will review all your medical information carefully to decide if this study is suitable for you.

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 an adult aged 18 or over?
Do you have a diagnosis of primary IgA nephropathy confirmed by a recent kidney biopsy?
Is your kidney function (eGFR) at or above 45 mL/min?
Are your blood pressure readings generally below 140/90 mmHg?
Have you been receiving the usual care for IgA nephropathy?
Do you have any other significant health conditions that might prevent you from joining, such as severe protein loss (nephrotic syndrome), other forms of IgA nephropathy, or a history of cancer or transplant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive doses of the study medication, PS-002. Since this is an early-stage study, you'll have close medical supervision. You’ll be asked to attend regular clinic visits for medical check-ups, blood tests, urine tests, and to monitor your general health and how you’re responding to the treatment. These assessments help the researchers understand how PS-002 is affecting your body and your kidney condition. After receiving the medication, you will be monitored for up to one year. There is also an option to take part in a long-term follow-up study for a total of five years, which would involve periodic checks on your health and kidney function.

Potential risks and benefits

Taking part in a study like this comes with potential benefits and risks. You might not directly benefit from the experimental treatment, but your participation could help researchers learn more about IgA nephropathy and potentially help others in the future. As with any new medication, there's a chance of side effects, some of which might be unexpected or serious. The study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Miami Hospital
Verified postcode
Miami, United States· Recruiting
The Johns Hopkins Hospital
Verified postcode
Baltimore, United States· Recruiting
University of Michigan Hospital
Verified postcode
Ann Arbor, United States· Not yet recruiting
Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Not yet recruiting
Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
Leicester General Hospital
Verified postcode
Leicester, United Kingdom· Not yet recruiting
Nottingham University Hospitals NHS Trust
Verified postcode
Nottingham, United Kingdom· Recruiting
Southmead Hospital
Verified postcode
Bristol, United Kingdom· Recruiting
Cardiff and Vale University Health Board
Verified postcode
Cardiff, United Kingdom· Not yet recruiting
Royal Infirmary of Edinburgh Clinical Research Facility
Verified postcode
Edinburgh, United Kingdom· Not yet recruiting
The Royal London Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is IgA nephropathy?

IgA nephropathy is a kidney disease where a protein called immunoglobulin A (IgA) builds up in the filtering parts of your kidneys, which can cause damage and affect how well your kidneys work over time.

What does 'first-in-human' mean?

This means that PS-002 is being given to people for the first time in an organised study. It's an important early step to understand its effects in humans.

Will I receive the standard treatment for my IgA nephropathy if I join this study?

Yes, participants are expected to continue receiving their best supportive care for IgA nephropathy alongside the study medication, as agreed with the study team.

How long will I be monitored for if I take part?

You'll be monitored for up to a year after receiving PS-002. There's also an option for a longer-term follow-up, which could extend for a total of five years.

What if I change my mind about participating?

You are free to leave the study at any time, for any reason. Your decision will not affect the medical care you receive.

How to find out more

Clinical Operations

contact@purespringtx.com +44 (0)20 3855 6324 Official trial record

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