RecruitingPHASE2INTERVENTIONAL

Imlifidase Prior to Kidney Transplant in Highly Sensitised Children

This study is investigating a new medicine called Imlifidase for children aged 1 to 17 who need a kidney transplant. These children are considered 'highly sensitised,' meaning their immune system is very likely to reject a new kidney, even after other treatments. The main goals are to see if Imlifidase can help their blood become compatible enough for a transplant and how well the new kidney works afterwards. Participants will stay in hospital as normal for a transplant and receive medicines to prevent rejection and infections. The study aims to provide hope for children who have limited options for a life-saving kidney transplant.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hansa Biopharma AB

Enrolment target

Start

02 Jun 2023

Estimated completion

31 Aug 2031

Kidney Transplantation in Highly Sensitized Patients

What is this study about?

This study is about a special medicine called Imlifidase. It's for children aged 1 to 17 who need a kidney transplant but have a very complicated immune system. For some children, their body is extra good at recognising foreign cells, which means they might reject a new kidney very easily. Even after trying other ways to calm down their immune system, they might still find it hard to get a compatible organ.

The main idea behind this study is to see if Imlifidase can help make these children's immune systems more accepting of a new kidney. The doctors want to find out if this medicine successfully changes certain markers in the child's blood, making a transplant possible. They also want to carefully watch how well the new kidney works after the transplant.

Ultimately, this research hopes to offer another option for children who urgently need a kidney transplant but haven't been able to find a suitable match through other methods. It's about giving more children a chance at a healthier life with a working kidney.

Key takeaways

A new medicine, Imlifidase, is being tested for children needing kidney transplants.
It's for children with challenging immune systems who struggle to find a kidney match.
The study looks at whether the medicine makes a transplant possible and how the kidney works.
Participants will follow normal transplant care, including hospital stays and medicines.
Long-term follow-up for up to 5 years is part of the study.
This could offer a new option for children with limited transplant possibilities.

Who may be eligible?

This study is looking for children aged 1 to 17 who have severe kidney disease and need a kidney transplant. They must be considered 'highly sensitised,' which means their immune system is very active and usually makes it hard to find a matching kidney. This might be because other treatments to calm their immune system haven't worked or because their blood tests show it would be very difficult to get a match using standard methods.

To join, a doctor must also believe the child is healthy enough for a transplant, even with their height and weight taken into account. The family, including the child if old enough, will need to agree to take part and follow the study instructions.

Children cannot join the study if they have had Imlifidase before, received certain immune-calming treatments recently, have serious infections, or a specific blood disorder called TTP (or a family history of it). They also cannot join if they have other very serious health problems that might make the transplant or study treatment too risky.

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.

Is your child aged between 1 and 17 years old?
Does your child have severe kidney disease and need a kidney transplant?
Has your child been told they are 'highly sensitised' or have a very difficult immune match profile?
Has your child tried other treatments to prepare for a transplant that haven't fully worked?
Has your child NOT had Imlifidase before?
Does your child not have serious infections or certain other specific health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you (or your child) will first need to go through some checks to make sure the study is right for you. Once a potential donor kidney is found, there will be a final check to confirm everything is suitable.

All children in the study will receive the Imlifidase medicine to prepare for the transplant. They will then have a kidney transplant, either from a deceased donor or a living donor. After the transplant, children will stay in hospital as part of their normal recovery. They will also receive standard medications to prevent their body from rejecting the new kidney and to protect against infections.

Doctors will closely monitor the child for any signs of their body trying to reject the new kidney. The intensive part of the study, following a kidney offer, lasts for 6 months for each patient. However, the study will continue to follow up with patients for up to 5 years after the transplant to understand the long-term effects and how well the new kidney is working.

Potential risks and benefits

Taking part in a study like this offers the potential benefit of enabling a life-saving kidney transplant for children who might otherwise struggle to find a match. However, there are potential risks, as with any medical treatment and transplant procedure. These include possible side effects from Imlifidase and other medications, and the general risks associated with surgery and suppressing the immune system, such as a higher chance of infections. The medical team will carefully explain all known risks. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your child’s standard medical care.

Locations (5)

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

HUS, Helsinki University Hospital
Verified postcode
Helsinki, Finland· Withdrawn
Robert Debre University Hospital
Verified postcode
Paris, France· Recruiting
Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica
Verified postcode
Barcelona, Spain· Recruiting
Karolinska University Hospital
Verified postcode
Huddinge, Sweden· Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'highly sensitised'?

It means your child's immune system is very active and could easily reject a new kidney, making it hard to find a match.

What does Imlifidase do?

It's a medicine being tested to help prepare the body so it's more likely to accept a donor kidney.

How long will the study follow my child?

The intense treatment period after a kidney offer is 6 months, but doctors will check on your child's progress for up to 5 years.

Will my child still take other medicines?

Yes, after the transplant, they'll receive standard medicines to prevent rejection and infections.

Can we stop participating if we change our minds?

Yes, you are free to withdraw from the study at any time without affecting your child's regular medical care.

How to find out more

Central Contact

clinicalstudyinfo@hansabiopharma.com +46 46 16 56 70 Official trial record

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