Long-term outcomes for highly sensitized kidney transplant patients after desensitization treatment
A Prospective, Long-term Confirmatory Follow up Trial in Highly Sensitized Patients Treated With Imlifidase or Standard of Care in the ConfIdeS (20-HMedIdeS-17) Trial
Hansa Biopharma AB · NCT05714514
This study looks at how well kidney transplants work and how long patients live after receiving a special treatment to reduce their immune system's reaction before the transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 64 (estimated) |
| Sex | All |
| Sponsor | Hansa Biopharma AB (industry) |
| Locations | 13 sites (Birmingham, Alabama and 12 other locations) |
| Trial ID | NCT05714514 on ClinicalTrials.gov |
What this trial studies
This observational follow-up study aims to assess long-term patient survival and kidney graft function in highly sensitized patients who underwent desensitization with imlifidase or standard of care prior to kidney transplantation. Participants will be monitored for up to five years after their initial treatment in the ConfIdeS study. The study will evaluate various outcomes, including patient survival, wait-list status, graft survival, kidney function, and health-related quality of life during routine follow-up visits. The goal is to gather comprehensive data on the effectiveness of desensitization strategies in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are highly sensitized patients who have previously participated in the ConfIdeS clinical trial.
Not a fit: Patients who are not highly sensitized or who have not participated in the ConfIdeS study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for highly sensitized patients awaiting kidney transplantation.
How similar studies have performed: Other studies have shown promise in desensitization approaches for kidney transplantation, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed Informed Consent obtained before any trial-related procedures. 2. Previous participation in the clinical trial ConfIdeS. Exclusion Criteria: 1. Inability by the judgement of the investigator to participate in the trial for any reason.
Where this trial is running
Birmingham, Alabama and 12 other locations
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States (RECRUITING)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
- Northwestern University, Dept. General Surgery, Div. Transplantation — Chicago, Illinois, United States (RECRUITING)
- John Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
- Cooperman Barnabas Medical Center — Livingston, New Jersey, United States (RECRUITING)
- New York University (NYU) Langone Transplant Institute, NYU Langone Health — New York, New York, United States (RECRUITING)
- Columbia University — New York, New York, United States (RECRUITING)
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
- Methodist Hospital Specialty and Transplant — San Antonio, Texas, United States (RECRUITING)
- University of Washington Medical Center — Seattle, Washington, United States (RECRUITING)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (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.
Conditions: Kidney Transplantation in Highly Sensitized Patients, Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor