Kidney Transplant Failure and RejectionNCT03611621

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

An observational study of Kidney Transplant Failure and Rejection, run by Hansa Biopharma AB at 6 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Transplant Failure and Rejection
What is being tested?: Imlifidase
How many people: 31 participants
Where: 6 sitesin 3 countries
Study dates: 27 Jun 2018to 14 Feb 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 3 countries.

Country

City, postcode or hospital

6 sites in 3 countries

United States3 sites

The Johns Hopkins Hospital
Baltimore, Maryland, 21205
Cedars-Sinai Medical Center
Los Angeles, California, 90048
New York University School of Medicine
New York, New York, 10016

Other trials in United States

Sweden2 sites

Karolinska University Hospital
Stockholm, 17176
Uppsala University Hospital
Uppsala, 751 85

Other trials in Sweden

France1 site

Necker Hospital
Paris, 75743

Other trials in France

About this study

Official title: A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

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
Being tested: Imlifidase
Medical subject headings: Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ImlifidaseDrug
Also called IdeS, HMED-IdeS
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Overall patient survival defined as time from transplantation to death for any cause
Measured: 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)).
Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation.
Measured: 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).
Kidney function as evaluated by analysis of plasma (P)-creatinine
Measured: 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).
Kidney function as evaluated by proteinuria by dipstick analysis
Measured: 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.
Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018).
The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR):
- a biopsy was taken at the time of the graft rejection episode
- histological evidence of an AMR was reported in the pathology report
- presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy
Measured: 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 Treatment of Graft Rejection Episodes.
Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications).
Measured: 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 Comorbidities.
Recording of comorbidities up until year 5 after treatment with imlifidase
Measured: 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 Treatments of Comorbidities.
Recording of concomitant immunosuppressive medication
Measured: 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5
Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)
Blood samples were analyzed for hemoglobulin (Hb)
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Differential analysis of leucocytes was done in blood samples
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)
Blood samples were analyzed for thrombocytes
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)
Blood samples were analyzed for total IgG levels.
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Donor Specific Antibodies (DSA)
DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of the Presence of BK Virus
Blood samples were analyzed for antibodies towards BK virus
Measured: 5 years after first dose of imlifidase (in the feeder study)
Assessment of the Immunogenicity of Imlifidase
Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay.
Measured: 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 Quality of Life (EQ-5D-5L).
Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L)
EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA [-0.109 - 1.000], France [-0.530 - 1.000], Denmark [-0.624 - 1.000], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden.
The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health.
Measured: 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 Quality of Life (KDQOL-SF).
Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF)
Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life.
Measured: 5 years after first dose of imlifidase (in the feeder study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 201814 Feb 2023

First posted2 Aug 2018
Study start27 Jun 2018
Primary completion14 Feb 2023
Study completion14 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03611621
Sponsor's protocol ID: 17-HMedIdeS-14
Status last verified: Jan 2025
First submitted: 5 Jul 2018
Last updated: 7 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lorant T, Lonze BE, Montgomery RA, Desai NM, Legendre C, Lundgren T, von Zur-Muhlen B, Vo AA, Sjoholm K, Runstrom A, Tollemar J, Jordan SC. Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients. Transpl Int. 2025 Nov 27;38:15425. doi: 10.3389/ti.2025.15425. eCollection 2025.
PubMed 41394519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pediatric Kidney Disease, Transplant;Failure,Kidney
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A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
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ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants
Kidney Transplant Failure and Rejection, Kidney Transplant; Complications
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation

All Kidney Transplant Failure and Rejection trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
ClinicalTrials.gov ID: NCT03611621
Acronym / sponsor ID: 17-HMedIdeS-14
Conditions: Kidney Transplant Failure and Rejection
Study type: Observational
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Hansa Biopharma ABIndustry (pharma, biotech, devices)
Study start: 27 Jun 2018 (actual)
Primary completion: 14 Feb 2023 (actual)
Study completion: 14 Feb 2023 (actual)
First posted: 2 Aug 2018 (actual)
Results: Posted 7 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ImlifidaseAlso: IdeS, HMED-IdeSThis 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.	Drug	–

Primary outcome

Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
Time frame: 5 years after first dose of imlifidase (in the feeder study)
The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.

17 secondary outcomes

Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.
Time frame: 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)).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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 Treatment of Graft Rejection Episodes.
Time frame: 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 Comorbidities.
Time frame: 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 Treatments of Comorbidities.
Time frame: 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5
Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of Donor Specific Antibodies (DSA)
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of the Presence of BK Virus
Time frame: 5 years after first dose of imlifidase (in the feeder study)
Assessment of the Immunogenicity of Imlifidase
Time frame: 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 Quality of Life (EQ-5D-5L).
Time frame: 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 Quality of Life (KDQOL-SF).
Time frame: 5 years after first dose of imlifidase (in the feeder study)

Results and safety

Results posted to the registry on 7 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Imlifidase	37	30

Primary outcome: Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.

Time frame: 5 years after first dose of imlifidase (in the feeder study). Number (95% Confidence Interval). Unit: percentage

Measure	Imlifidase n = 37
Value	91 (75 to 97)

Population analysed: The primary endpoint, overall graft survival, was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored at the time of occurrence: withdrawal from the trial without graft loss, death not caused by graft loss, and end of trial without graft loss.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) related to trial procedures or to clinically significant safety laboratory values were recorded from time of informed consent to end of trial, up to 4y and 6m. AEs were not collected for the 6 patients that had lost their graft (n=3) or who died (n=3) after the end of the feeder trials, since these patients were not actively enrolled in the current trial. In the feeder trials AEs were recorded for each patient from time of informed consent to end of trial, up to 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Imlifidase	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41394519Lorant T, Lonze BE, Montgomery RA, Desai NM, Legendre C, Lundgren T, von Zur-Muhlen B, Vo AA, Sjoholm K, Runstrom A, Tollemar J, Jordan SC. Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients. Transpl Int. 2025 Nov 27;38:15425. doi: 10.3389/ti.2025.15425. eCollection 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Operations study director

Hansa Biopharma AB

6 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant Failure and Rejection, run by Hansa Biopharma AB at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Sweden, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. (time frame: 5 years after first dose of imlifidase (in the feeder study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03611621, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.