A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

NCT03611621 | Completed Results FDA Drug

• 1 other identifier: 17-HMedIdeS-14
• Study Type: observational
• Target: 31
• Locations: 3 countries
• Sites: 6

Brief Summary

The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected. This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.

Conditions

Kidney Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (1)

• Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.

  The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.

  5 years after first dose of imlifidase (in the feeder study)

Secondary Outcomes (17)

• Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.

  5 years after first dose of imlifidase (in the feeder study)

• Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).

  5 years after first dose of imlifidase (in the feeder study)

• Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).

  5 years after first dose of imlifidase (in the feeder study)

• Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).

  5 years after first dose of imlifidase (in the feeder study)

• Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.

  5 years after first dose of imlifidase (in the feeder study)

Interventions

Imlifidase DRUG

This is a five year, long-term follow up, observational study. The study will primarily determine the time of graft survival in subjects who have received imlifidase prior to kidney transplantation. Subjects who have participated, or are currently participating, in the imlifidase kidney transplantation studies (called feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS- 04 and 15-HMedIdeS-06 will be included. The subjects will attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration.

Also known as: IdeS, HMED-IdeS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects that have participated, or are currently participating, in the imlifidase kidney transplantation studies; 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06 will be included.

You may qualify if:

• Signed Informed Consent obtained before any study-related procedures
• Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06

You may not qualify if:

• Individuals deemed unable to comply with the protocol
• Inability by the judgment of the investigator to participate in the study for other reasons

Sponsors & Collaborators

• Hansa Biopharma AB: lead

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Necker Hospital

Paris, 75743, France

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (storage time: maximum 2 years after completion of the study report according to local regulations)

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Mac-1-like protein, Streptococcus

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Results Point of Contact

• Title: Study Director
• Organization: Hansa Biopharma AB

clinicalstudyinfo@hansabiopharma.com

+46 46 16 56 70

Study Officials

• Clinical Operations

  Hansa Biopharma AB

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 2, 2018
• Study Start: June 27, 2018
• Primary Completion: February 14, 2023
• Study Completion: February 14, 2023
• Last Updated: February 7, 2025
• Results First Posted: February 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); SE (2); US (3)