Imlifidase Desensitization for Kidney Transplant Patients

(ConfIdeS Trial)

Recruiting at 26 trial locations

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hansa Biopharma AB

Must not be taking: High dose IVIg

Disqualifiers: Pregnancy, HIV, Hepatitis, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

64 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing imlifidase, a treatment that removes harmful antibodies, in highly sensitized kidney transplant patients. These patients are at high risk of rejecting a new kidney due to their antibodies. Imlifidase helps clear these antibodies to prevent rejection and holds promise to be a game-changer for sensitized patients in need of lifesaving organ transplants.

Do I need to stop my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug imlifidase for kidney transplant patients?

Imlifidase has been shown to quickly reduce antibodies that can cause rejection in kidney transplants, allowing patients with few donor options to receive transplants. It has been approved in Europe for use in highly sensitized patients, and studies have demonstrated its ability to convert a positive crossmatch test to negative, facilitating successful transplants. ^{1 2 3 4 5}

Is imlifidase safe for use in humans?

Imlifidase has been evaluated in clinical trials for kidney transplant patients and is considered safe for use in highly sensitized patients, as it effectively reduces antibodies that can cause transplant rejection. It has received approval in the EU for this purpose, and ongoing studies continue to assess its safety and effectiveness in other conditions. ^{1 2 4 5 6}

How is the drug imlifidase unique for kidney transplant patients?

Imlifidase is unique because it rapidly breaks down antibodies that would otherwise prevent a kidney transplant, allowing highly sensitized patients to receive transplants from donors they would typically be incompatible with. This is achieved through its ability to cleave immunoglobulin G (IgG) antibodies, which is not possible with other existing treatments. ^{1 2 4 5 7}

Research Team

Clinical Operations

Principal Investigator

Hansa Biopharma AB

Eligibility Criteria

This trial is for adults aged 18-70 with chronic kidney disease stage 5, highly sensitized (cPRA ≥99.9%), and on the waitlist for a deceased donor kidney transplant. They must be able to follow the study plan and join a 4-year extension trial. Pregnant or breastfeeding individuals, those with certain infections like HIV/HBV/HCV, active tuberculosis, or severe conditions that prevent transplantation are excluded.

Inclusion Criteria

I have severe kidney disease, am highly sensitized, and waiting for a donor kidney.

Virtual crossmatch (vXM), predictive of a positive crossmatch to an available deceased donor (DD)

Willingness and ability to comply with the protocol

Exclusion Criteria

The doctor thinks I might not be able to take part in the trial for some reason.

Positive test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (according to local hospital routines)

I am using or willing to use two effective birth control methods if I can have children.

Timeline

Pre-screening

Participants are screened for eligibility to participate in the trial

Not specified

Desensitization and Transplantation

Participants receive desensitization treatment and undergo kidney transplantation

Within 24 hours prior to transplantation

1 visit (in-person)

Induction and Maintenance Therapy

All transplanted patients receive induction therapy and maintenance immunosuppression

Immediately post-transplantation

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits as per protocol

Treatment Details

Interventions

• Anti-CD20 antibodies
• Eculizumab
• Imlifidase
• IVIg
• PLEX

Trial Overview The study tests if imlifidase used before a kidney transplant can improve renal function in patients who have high antibody levels against potential donors. It's compared to standard care including anti-CD20 antibodies and other treatments like PLEX and IVIg in an open-label, randomized Phase 3 trial over one year.

Participant Groups

Group I: Imlifidase Experimental Treatment 1 Intervention

Imlifidase, is provided as a freeze-dried powder for concentrate for solution for infusion, 11 mg per vial. After reconstitution with sterile water for injection, the concentrate contains 10 mg/mL imlifidase. Imlifidase is administered intravenously as one infusion of 0.25 mg/kg over 15 minutes generally 24 hours prior to transplantation. A second dose of 0.25 mg/kg may be given if the first imlifidase dose is considered not to have had sufficient effect.

Group II: Best available treatment Experimental Treatment 5 Interventions

Institution-specific desensitization protocol (i.e. any combination of plasma exchange (PLEX), intravenous IVIg, anti-CD20 antibody, and eculizumab) where appropriate OR remain on wait list for a more compatible organ offer

Who Is Running the Clinical Trial?

Hansa Biopharma AB

Lead Sponsor

Trials

20

Recruited

780+

References

1. United States pubmed.ncbi.nlm.nih.gov

Imlifidase Desensitization in HLA-incompatible Kidney Transplantation: Finding the Sweet Spot. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Imlifidase: First Approval. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A review of imlifidase in solid organ transplantation. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Imlifidase for Kidney Transplantation of Highly Sensitized Patients With a Positive Crossmatch: The French Consensus Guidelines. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

First use of imlifidase desensitization in a highly sensitized lung transplant candidate: a case report. [2023]