RECRUITING

Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177).

Official Title

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

Quick Facts

Study Start:2023-04-21
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05714514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed Informed Consent obtained before any trial-related procedures.
  2. 2. Previous participation in the clinical trial ConfIdeS.
  1. 1. Inability by the judgement of the investigator to participate in the trial for any reason.

Contacts and Locations

Study Contact

Central Contact
CONTACT
+46 46 16 56 70
clinicalstudyinfo@hansabiopharma.com

Principal Investigator

Therese Åkerfeldt
STUDY_DIRECTOR
Hansa Biopharma AB

Study Locations (Sites)

University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35249
United States
John Hopkins Hospital
Baltimore, Maryland, 21287
United States
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, 10016
United States
Columbia University
New York, New York, 10032
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Methodist Hospital Specialty and Transplant
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Hansa Biopharma AB

  • Therese Åkerfeldt, STUDY_DIRECTOR, Hansa Biopharma AB

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-21
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2023-04-21
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Desensitization
  • Highly sensitized
  • Positive crossmatch
  • Unlikely to be transplanted
  • Renal transplantation
  • Deceased donor

Additional Relevant MeSH Terms

  • Kidney Transplantation in Highly Sensitized Patients