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New drug may help Hard-to-Transplant kidney patients stay off dialysis longer

NCT ID NCT05714514

Disease control Sponsor: Hansa Biopharma AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 64 highly sensitized kidney transplant patients who previously received either imlifidase or standard care in an earlier trial. Researchers will track how many patients are alive and free of dialysis at 3 and 5 years, as well as graft survival. The goal is to see if imlifidase helps these hard-to-match patients achieve better long-term transplant success.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Imlifidase
What this could lead to
If successful, this could show that imlifidase helps highly sensitized patients receive a kidney transplant and maintain good long-term outcomes.
What could go wrong
This is a small follow-up study (64 patients) with no new treatment, so results may not apply broadly. Long-term risks like graft rejection or side effects remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients who have participated in the clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177)

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney transplantation in highly sensitized patients

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Columbia University

    New York, New York, 10032, United States

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07039, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • John Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Methodist Hospital Specialty and Transplant

    San Antonio, Texas, 78229, United States

  • New York University (NYU) Langone Transplant Institute, NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern University, Dept. General Surgery, Div. Transplantation

    Chicago, Illinois, 60611, United States

  • University of Alabama at Birmingham (UAB) Hospital

    Birmingham, Alabama, 35249, United States

  • University of Chicago, Department of Surgery, Clinical Research Center

    Chicago, Illinois, 60637, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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