Imlifidase Desensitization for Kidney Transplant Patients

(ConfIdeS Trial)

No longer recruiting at 28 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of imlifidase for individuals needing a kidney transplant but facing challenges due to high sensitivity to donor tissues. The study compares imlifidase treatment, which reduces immune system reactions, with standard care methods. It targets those with chronic kidney disease who are highly sensitized and have struggled to find a compatible donor. Participants must exhibit a strong immune response to potential donors (cPRA ≥99.9%) and be on the waiting list for a deceased donor kidney transplant. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that imlifidase is generally safe for patients needing a kidney transplant, with no major safety issues identified. Studies indicate that this treatment lowers harmful antibodies, aiding in successful transplants. Three years after treatment, 90% of patients remained alive, and 84% had a functioning transplanted kidney. These outcomes suggest that imlifidase is a safe option for highly sensitized individuals requiring a kidney transplant. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for kidney transplant patients?

Imlifidase is unique because it offers a new approach for desensitizing kidney transplant patients. Unlike standard treatments that typically involve a combination of plasma exchange, IVIg, and other antibodies, imlifidase works by specifically targeting and breaking down antibodies that can cause organ rejection. This targeted action allows it to act quickly, potentially preparing patients for transplantation in just 24 hours. Researchers are excited about imlifidase because it could significantly increase the number of patients eligible for transplants by expanding the pool of compatible donors.

What evidence suggests that this trial's treatments could be effective for kidney transplant patients?

Research has shown that imlifidase, which participants in this trial may receive, can aid kidney transplant patients with strong immune reactions against donor tissue. Studies found that after using imlifidase to reduce these reactions, 84% of transplanted kidneys functioned well after three years, and 90% of patients survived. Long-term results up to five years also appear promising, with similar survival rates and stable kidney function. This treatment lowers harmful antibodies in the body, enabling a successful transplant even when usual immune challenges exist. Overall, imlifidase offers a hopeful option for patients who might otherwise struggle to find a match. ^{2 6 7 8 9}

Who Is on the Research Team?

Clinical Operations

Principal Investigator

Hansa Biopharma AB

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9290474/

Outcomes at 3 years posttransplant in imlifidase‐desensitized ... Three years after imlifidase‐enabled desensitization and transplantation, the death‐censored allograft survival was 84%, patient survival 90%, and mean eGFR was ...

2. hansabiopharma.com hansabiopharma.com/media/press-releases/2025/hansa-biopharma-presents-positive-outcomes-of-five-year-follow-up-study-of-imlifidase-in-kidney-transplantation-at-esot-congress-2025-in-london/

Hansa Biopharma presents positive outcomes of five-year ... This study demonstrated for the first time that HLA-incompatible transplantation following desensitization with imlifidase is a viable option ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590059525001128

Desensitization With Imlifidase: Overcoming Immunological ... Short-term outcomes were encouraging, with stable kidney function and significant DSA reduction at 9 months. This case highlights the potential of imlifidase in ...

4. journals.lww.com journals.lww.com/transplantationdirect/fulltext/2025/02000/clinical_outcomes_and_donor_specific_antibody.3.aspx

Clinical Outcomes and Donor-specific Antibody Rebound 5 ... Five-year outcomes of imlifidase-enabled incompatible transplants are overall favorable. DSA rebound is common, but antibody strength lessens in the long term.

5. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2024.13886/full

Desensitization With Imlifidase for HLA-Incompatible ... The reported 3 and 5-year data on Imlifidase HLAi KTx [15], showed positive outcomes with 90% patient and graft survival (death censored) of 84% ...

6. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2023.11244/full

Imlifidase for Kidney Transplantation of Highly Sensitized ... No safety signal was reported. Based on these data, Imlifidase is now indicated as a desensitization agent of highly sensitized adult kidney ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05369975

Efficacy and Safety in Imlifidase Desensitized Kidney Tx ... All patients with donor specific antibodies (DSAs) are at risk for antibody-mediated reactions (AMRs). Imlifidase removes DSA quickly and efficiently at the ...

8. ema.europa.eu ema.europa.eu/en/documents/rmp/idefirix-epar-risk-management-plan_en.pdf

EU Risk Management Plan (RMP) for Idefirix (imlifidase) Indication: Idefirix is indicated for desensitization treatment of highly sensitized adult kidney transplant patients with positive crossmatch.

9. journals.lww.com journals.lww.com/transplantjournal/fulltext/2021/08000/imlifidase_desensitization_in_crossmatch_positive,.26.aspx

Imlifidase Desensitization in Crossmatch-positive, Highly... This study investigates the efficacy and safety of imlifidase in converting a positive crossmatch test to negative, allowing highly sensitized patients to be ...