3 Participants Needed

Imlifidase for Kidney Transplantation

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Overseen ByCentral Contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

CO

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
See 2 more

Exclusion Criteria

EBV seronegative or with unknown EBV serostatus
Positive serology for HIV
Breast-feeding or pregnancy
See 16 more

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?
1Treatment groups
Experimental Treatment
Group I: ImlifidaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hansa Biopharma AB

Lead Sponsor

Trials
20
Recruited
780+

Citations

Imlifidase for the treatment of anti-HLA antibody-mediated processes in kidney transplantation. [2023]
Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. [2023]
Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). [2023]
Imlifidase Desensitization in HLA-incompatible Kidney Transplantation: Finding the Sweet Spot. [2023]
Imlifidase: First Approval. [2021]
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