Imlifidase for Kidney Transplantation

Overseen By Central Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hansa Biopharma AB

Must not be taking: Investigational drugs

Disqualifiers: Pregnancy, HIV, Active infections, others

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

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of drugs, including imlifidase (an enzyme-based treatment), to determine if they can prevent rejection in patients receiving a kidney transplant from a living donor. The goal is to reduce donor-specific antibodies that can cause rejection of the new kidney in individuals with chronic kidney disease who have a positive match to their donor. This study may suit individuals with chronic kidney disease who are highly sensitized, meaning their body is likely to reject a new kidney, and are on the waiting list for a kidney transplant with a living donor. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether 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 imlifidase is likely to be safe for humans?

Research has shown that imlifidase is generally safe for kidney transplant patients. It is approved in Europe to help patients receive kidneys even when their bodies might otherwise reject them, indicating its safety for similar uses.

One study focused on patients highly likely to reject a transplant and found that imlifidase was effective and generally safe for these patients. However, like all treatments, it carries some risks. Unwanted side effects can occur, but they are usually manageable. Some patients experienced reactions, often mild.

In summary, imlifidase has been studied and approved for certain kidney transplant cases, demonstrating it is usually safe to use. Participants should discuss potential risks with their doctors before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Imlifidase is unique because it offers a novel approach for kidney transplantation by targeting and breaking down specific antibodies that can interfere with the success of the transplant. Unlike traditional treatments that often involve long-term immunosuppressive drugs to prevent organ rejection, Imlifidase works quickly, being administered just before the transplant to neutralize problematic antibodies. This rapid action could potentially improve the chances of a successful transplant and reduce the need for prolonged, intense medication regimens. Researchers are excited about Imlifidase because it represents a promising shift towards more efficient and targeted transplant preparation, with the potential for fewer side effects.

What evidence suggests that imlifidase might be an effective treatment for chronic kidney disease?

Research shows that imlifidase, the treatment being studied in this trial, can greatly benefit patients receiving kidney transplants. Studies have found that patients who received imlifidase had better kidney function one year after their transplant, with an average function level of 51.5 mL/min/1.73m². Another study reported that three years after treatment with imlifidase, 84% of the transplanted kidneys were still functioning well, and 90% of the patients were alive. Imlifidase also lowers donor-specific antibodies, proteins that can attack a new kidney, reducing the risk of rejection. These findings suggest that imlifidase could be a promising treatment for improving transplant success in patients at high risk of rejection. ^{5 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 on the UNOS waiting list for a kidney transplant, highly sensitized with specific cPRA levels or long wait times in exchange programs. They must have a living donor with whom they have a positive crossmatch but not be pregnant, breastfeeding, or incompatible by blood type. Participants should not have certain infections, recent IVIg treatments, or severe other conditions and must agree to use effective contraception.

Inclusion Criteria

I am willing and able to follow the study's requirements.

Signed Informed Consent obtained before any trial-related procedures

Highly sensitized patients registered on the UNOS waiting list for kidney transplantation with a positive crossmatch towards a living donor

Exclusion Criteria

EBV seronegative or with unknown EBV serostatus

Positive serology for HIV

Breast-feeding or pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Pre-treatment

Patients start treatment with belatacept and bortezomib about 3 weeks prior to the imlifidase infusion and transplantation

3 weeks

Transplantation and Initial Treatment

Imlifidase is administered prior to transplantation, followed by rituximab and IVIg post-transplantation

2 weeks

Hospitalization for approximately 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including 9 follow-up visits to the clinic

6 months

9 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Imlifidase

Trial Overview The study tests if imlifidase combined with bortezomib, belatacept, rituximab and IVIg can lower donor-specific antibodies and prevent antibody-mediated rejection in patients after receiving a kidney from a living donor who matches positively on crossmatch tests. The effectiveness will be monitored over three months post-transplantation.

How Is the Trial Designed?

Group I: Imlifidase Experimental Treatment 1 Intervention

Imlifidase is administered intravenously as one dose of 0.25 mg/kg over 15 minutes within the 24-hour period prior to transplantation. (A second dose may be given if the crossmatch test at 4 hours after the first dose remains positive.)

Who Is Running the Clinical Trial?

Hansa Biopharma AB

Lead Sponsor

Trials

20

Recruited

780+

Citations

1. hansabiopharma.com hansabiopharma.com/media/press-releases/2025/imlifidase-successfully-meets-primary-endpoint-in-pivotal-us-phase-3-confides-trial-in-kidney-transplantation/

Imlifidase successfully meets primary endpoint in pivotal ... Patients who were randomized to receive imlifidase showed superior kidney function at 12 months of 51.5 mL/min/1.73m2, compared to patients ...

2. 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 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05369975

Efficacy and Safety in Imlifidase Desensitized Kidney Tx ... An open-label post authorization efficacy and safety study evaluating graft failure-free survival at 1-year in highly sensitized end-stage renal disease ...

5. academic.oup.com academic.oup.com/ckj/article/17/3/sfae033/7604604

Imlifidase in kidney transplantation - Oxford Academic A 100% patient survival and 88.9% allograft survival were achieved at the 6-months post-transplant follow-up, while both graft losses were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10949912/

Imlifidase in kidney transplantation - PMC The efficiency and safety of imlifidase therapy, including the impact of AMR, were evaluated in a pooled analysis study by Kjellman et al. [17] involving four ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05753930

NCT05753930 | Imlifidase Prior to Kidney Transplant in ... The trial includes a follow-up part to collect long-term efficacy and safety data up to 5 years after the transplantation. ... renal transplant from a living or ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924018540

Imlifidase in Highly Sensitized Kidney Transplant ... Imlifidase is authorized for desensitization of highly sensitized adult kidney transplant candidates with a positive crossmatch (XM) against a deceased donor.

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

EU Risk Management Plan (RMP) for Idefirix (imlifidase) Based on these data, ranging from 5.2% to 26% of patients being highly sensitized, it was considered acceptable to assume that 15% of the ...