Using photopheresis to prevent kidney transplant rejection in highly sensitized patients
Impact of Photopheresis in the Prevention of Acute Rejection in Highly Sensitized de Novo Kidney Transplant Recipients
This study is testing if a special light treatment combined with regular medication can help prevent kidney transplant rejection in patients who are highly sensitive to donor organs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica Academic / other |
| Drugs / interventions | Rituximab, Eculizumab |
| Locations | 1 site (Barcelona, Please Select) |
| Trial ID | NCT04414735 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of extracorporeal photopheresis combined with standard immunosuppression compared to standard immunosuppression alone in preventing acute rejection in highly sensitized kidney transplant recipients. The trial is unicentric and randomized, focusing on patients with a calculated panel reactive antibody (cPRA) of 90% or higher. Participants will be monitored for signs of acute rejection post-transplant to determine the superiority of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a cPRA of 90% or higher who are undergoing deceased-donor kidney transplantation.
Not a fit: Patients currently participating in another interventional clinical trial or those who have used specific medications like Rituximab or Eculizumab shortly before or after transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute rejection in highly sensitized kidney transplant recipients.
How similar studies have performed: While the use of photopheresis in transplant settings has been explored, this specific combination with standard immunosuppression in highly sensitized patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona, Please Select
- Deparment of Nephology and Kidney Transplant — Barcelona, Please Select, Spain (Recruiting)
Study contacts
- Study coordinator: Diekmann
- Email: fdiekman@clinic.cat
- Phone: +34932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.