UnknownNot Applicable

Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients

Spain30 participantsStarted 2022-08-17

Plain-language summary

The aim of the present study is to evaluate the superiority of photopheresis in combination with the standard immunosuppression vs standard immunosuppression alone for the prevention of acute rejection in highly sensitized kidney transplant recipients (cPRA ≥90%). Unicentric, randomized, open study.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Sensitized (cPRA ≥90%) candidates for a deceased-donor kidney transplantation * Recipients between 18 and 75 years old * Patients are able to understand and sign informed consent (Annex 1). Exclusion Criteria: * Participation in another interventional clinical trial. * Use of Rituximab or Eculizumab at the time of transplant or in the first 24 hours post-transplant. * Persons with any dependency on the researcher or employee by the responsible institution or researcher. As well as people detained by legal order.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to first histological rejection in the first year of kidney transplantation.

Timeframe: 1 year after kidney transplantation

Trial details

NCT IDNCT04414735

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03

Contact for this trial

Diekmann

+34932275400 fdiekman@clinic.cat

View on ClinicalTrials.gov More Kidney Transplant Rejection trials