Long-term follow-up of kidney transplant patients treated with imlifidase
A Prospective, Post-authorisation Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation, Including a Non-comparative Concurrent Reference Cohort
This study looks at how well imlifidase works to prevent kidney rejection in patients who had a transplant and were treated with it, tracking their health for up to 5 years.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 76 Years |
| Sex | All |
| Sponsor | Hansa Biopharma AB Industry-sponsored |
| Locations | 14 sites (Vienna and 13 other locations) |
| Trial ID | NCT05937750 on ClinicalTrials.gov |
What this trial studies
This trial is a long-term follow-up for patients who were previously treated with imlifidase before kidney transplantation. It includes a non-comparative cohort of patients who received standard care. The aim is to evaluate the long-term efficacy and safety of imlifidase in preventing kidney rejection over a period of up to 5 years post-transplant. Data will be collected on kidney function and side effects to fulfill regulatory requirements from the European Medicines Agency.
Who should consider this trial
Good fit: Ideal candidates are patients who were previously treated with imlifidase and underwent kidney transplantation in the PAES trial.
Not a fit: Patients who did not participate in the PAES trial or were not treated with imlifidase prior to transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of imlifidase in kidney transplantation.
How similar studies have performed: Other studies have shown promising results with imlifidase in kidney transplantation, indicating potential for success in this follow-up trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed Informed Consent obtained before any trial-related procedures * Willingness and ability to comply with the protocol * Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES) Exclusion Criteria: * Inability by the judgment of the investigator to participate in the trial for other reasons
Where this trial is running
Vienna and 13 other locations
- Medizinische Universitaet Wien — Vienna, Austria (Recruiting)
- Nephrology Clinic Vídeňská 1958/9 — Prague, Czechia (Recruiting)
- Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume — Bois-Guillaume, Normandy, France (Recruiting)
- Hôpital Necker - Enfants Malades — Paris, France (Recruiting)
- Azienda Ospedaliera di Padova — Padova, Italy (Recruiting)
- Azienda Ospedaliero - Universitaria di Parma — Parma, Italy (Recruiting)
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Erasmus University Medical Center — Rotterdam, Netherlands (Recruiting)
- Hospital Del Mar, Servicio de Nefrología — Barcelona, Spain (Recruiting)
- Hospital Universitario del Vall d´Hebron — Barcelona, Spain (Recruiting)
- Unidad de Trasplante Renal — Barcelona, Spain (Recruiting)
- Hospital Universitario 12 De Octubre — Madrid, Spain (Recruiting)
- Karolinska University Hospital, — Huddinge, Stockholm County, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Central Contact
- Email: clinicalstudyinfo@hansabiopharma.com
- Phone: +46 46 16 56 70
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.