Kidney Transplantation in Highly Sensitized PatientsConfIdeSLTFUNCT05714514
Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys
An observational study of Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 14 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation in Highly Sensitized Patients
- What is being tested?
- Imlifidase administered in the ConfIdeS study and Best available treatment administered in the ConfIdeS study
- How many people
- 64 participants
- Where
- 14 sitesUnited States
- Study dates
- 21 Apr 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177)
Who may be able to join
- Signed Informed Consent obtained before any trial-related procedures.
- Previous participation in the clinical trial ConfIdeS.
Who cannot join
- 1. Inability by the judgement of the investigator to participate in the trial for any reason.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
John Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University, Dept. General Surgery, Div. Transplantation
Chicago, Illinois, 60611
University of Chicago, Department of Surgery, Clinical Research Center
Chicago, Illinois, 60637
Houston Methodist Hospital
Houston, Texas, 77030
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, 10016
Columbia University
New York, New York, 10032
Methodist Hospital Specialty and Transplant
San Antonio, Texas, 78229
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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).
Read the detailed description
This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer.
After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.
Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.
- Being tested
- Imlifidase administered in the ConfIdeS study, Best available treatment administered in the ConfIdeS study
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imlifidase administered in the ConfIdeS studyDrug
Also called IdeS, HMED-IdeS
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc- fragment and efficiently neutralizes Fc-mediated activities of IgG.
Best available treatment administered in the ConfIdeS studyOther
Institution-specific desensitization treatment prior to kidney transplantation in the ConfIdeS study OR remain on wait list for a more compatible organ offer if desensitization with institutional protocol is not appropriate
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase administered in the ConfIdeS study | Not described Receives: Drug: Imlifidase administered in the ConfIdeS study | |
| Best available treatment administered in the ConfIdeS study | Not described Receives: Other: Best available treatment administered in the ConfIdeS study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive and free of dialysis at 3 years
Measured: 3 years after randomization in the ConfIdeS study
Secondary outcomes (9)
Proportion of patients alive and free of dialysis at 5 years
Measured: 5 years after randomization in the ConfIdeS study
Proportion of patients alive at 3 and 5 years
Measured: 3 and 5 years after randomization in the ConfIdeS study
Graft failure-free survival rates at 3 and 5 years
Graft failure-free survival is defined as time from randomization to the fist of either graft failure or death
Measured: 3 and 5 years after randomization in the ConfIdeS study
Graft survival rates at 3 and 5 years
To be assessed in patients who were transplanted at randomization in the ConfIdeS study
Measured: 3 and 5 years after randomization in the ConfIdeS study
Number of patients per wait-list category
The different wait-list categories are: transplanted, active, temporary inactive, inactive, or deceased
Measured: 3 and 5 years after randomization in the ConfIdeS study
Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years
eGFR is a measure of kidney function. eGFR will be calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. Kidney disease is characterised by a decreased eGFR value. eGFR will be set to zero, for randomized patients who do not undergo transplantation, lose their graft or die.
Measured: 3 and 5 years after randomization in the ConfIdeS study
Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)
Measured: 3 and 5 years after randomization in the ConfIdeS study
Proportion of patients with biopsy confirmed cell-mediated rejection
Measured: 3 and 5 years after randomization in the ConfIdeS study
Treatment of graft rejection episodes
Any treatments given during rejection episodes will be recorded
Measured: 3 and 5 years after randomization in the ConfIdeS study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start21 Apr 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplantation in Highly Sensitized PatientsStudies 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
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansa Biopharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Therese Åkerfeldt, Study director, Hansa Biopharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714514
- Sponsor's protocol ID
- 21-HMedIdes-25
- Acronym
- ConfIdeSLTFU
- Status last verified
- Nov 2025
- First submitted
- 27 Jan 2023
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05714514
- Acronym / sponsor ID
- ConfIdeSLTFU / 21-HMedIdes-25
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer.
After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.
Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imlifidase administered in the ConfIdeS study | – | Drug: Imlifidase administered in the ConfIdeS study |
| Best available treatment administered in the ConfIdeS study | – | Other: Best available treatment administered in the ConfIdeS study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177)
Key inclusion criteria (2 listed)
- Signed Informed Consent obtained before any trial-related procedures.
- Previous participation in the clinical trial ConfIdeS.
Key exclusion criteria (1 listed)
- 1. Inability by the judgement of the investigator to participate in the trial for any reason.
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 |
|---|---|---|
| Imlifidase administered in the ConfIdeS studyAlso: IdeS, HMED-IdeSImlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc- fragment and efficiently neutralizes Fc-mediated activities of IgG. | Drug | Imlifidase administered in the ConfIdeS study |
| Best available treatment administered in the ConfIdeS studyInstitution-specific desensitization treatment prior to kidney transplantation in the ConfIdeS study OR remain on wait list for a more compatible organ offer if desensitization with institutional protocol is not appropriate | Other | Best available treatment administered in the ConfIdeS study |
Primary outcome
Proportion of patients alive and free of dialysis at 3 years
Time frame: 3 years after randomization in the ConfIdeS study
9 secondary outcomes
Proportion of patients alive and free of dialysis at 5 years
Time frame: 5 years after randomization in the ConfIdeS study
Proportion of patients alive at 3 and 5 years
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Graft failure-free survival rates at 3 and 5 years
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Graft survival rates at 3 and 5 years
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Number of patients per wait-list category
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Mean estimated glomerular filtration rate (eGFR) at 3 and 5 years
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Proportion of patients with biopsy- and serology confirmed antibody-mediated rejection (AMR)
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Proportion of patients with biopsy confirmed cell-mediated rejection
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Treatment of graft rejection episodes
Time frame: 3 and 5 years after randomization in the ConfIdeS study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Therese Åkerfeldt study director
Hansa Biopharma AB
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 14 sites in United States.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of patients alive and free of dialysis at 3 years (time frame: 3 years after randomization in the ConfIdeS study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.