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

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses a combination of medications to help highly sensitized patients with chronic kidney disease accept a new kidney from a living donor. The medications work together to reduce harmful antibodies and immune responses, making transplantation more likely to succeed.

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.

What makes the drug Imlifidase unique for kidney transplantation?

Imlifidase is unique because it rapidly breaks down IgG antibodies, allowing kidney transplants to occur between donors and recipients who were previously incompatible due to these antibodies. This makes it a valuable option for patients with limited donor matches, as it enables transplantation that would otherwise be impossible. ^{1 2 3 4 5}

Research Team

Clinical Operations

Principal Investigator

Hansa Biopharma AB

Eligibility Criteria

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.

I am between 18 and 70 years old.

Signed Informed Consent obtained before any trial-related procedures

Exclusion Criteria

EBV seronegative or with unknown EBV serostatus

Positive serology for HIV

Breast-feeding or pregnancy

Timeline

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)

Treatment Details

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.

Participant Groups

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+

References

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

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

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

Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. [2023]

3. 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]

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

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

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

Imlifidase: First Approval. [2021]