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Enzyme

Imlifidase for Kidney Transplantation

Phase 2
Waitlist Available
Research Sponsored by Hansa Biopharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female age 18 to 70 years at the time of screening
Highly sensitized patients registered on the UNOS waiting list for kidney transplantation with cPRA ≥ 99.9%
Must not have
A history of a proven hypercoagulable condition
Present, or history of, thrombotic thrombocytopenic purpura (TTP) or known familial history of TTP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 hours before imlifidase dose until day 10
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of imlifidase may include allergic reactions and increased risk of infections due to its immune-modifying properties. Side effects related to the combination drugs like bortezomib could involve nerve damage or digestive issues; belatacept might increase infection risks; rituximab can cause infusion reactions; IVIg may lead to headaches or thrombosis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I am on the UNOS waiting list for a kidney transplant with a cPRA of 99.9% or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of blood clotting disorders.
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I have or had a blood disorder called TTP, or it runs in my family.
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I do not have severe heart or lung conditions needing close watch.
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I haven't taken any experimental drugs recently, except for imlifidase.
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I have active tuberculosis.
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I have been treated with imlifidase before.
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I show signs of hepatitis B, hepatitis C, CMV, or EBV infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 hours before imlifidase dose until day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 hours before imlifidase dose until day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of patients with DSA rebound
Secondary study objectives
Anti-drug antibodies (ADA) levels
Change in patient-reported life participation, as measured PROMIS-SF-8a
Graft survival
+17 more

Side effects data

From 2020 Phase 2 trial • 15 Patients • NCT03157037
40%
Anaemia
27%
Nausea
20%
Hypertension
13%
Vomiting
13%
Urinary tract infection
13%
Hyperglycaemia
13%
Diarrhoea
13%
Tinnitus
13%
Leukopenia
7%
Diarrhea
7%
Back pain
7%
Decreased appetite
7%
Haematuria
7%
Pyrexia
7%
Viral infection
7%
Pneumonia
7%
Dehydration
7%
Muscle spasms
7%
Sinus pain
7%
Cardiac failure
7%
Hypogammaglobulinaemia
7%
Blood iron decreased
7%
Pneumonia klebsiella
7%
Foreign body sensation in eyes
7%
Fatigue
7%
Herpes zoster
7%
Hyperphosphataemia
7%
Thrombophlebitis
7%
Thrombocytopenia
7%
Cryoglobulinaemia
7%
Clostridium difficile infection
7%
Red blood cell count decreased
7%
Hypoglycaemia
7%
Steroid diabetes
7%
Rash erythematous
7%
Urticaria
7%
Arthralgia
7%
Ecchymosis
7%
Dyspnoea
7%
Hyperhidrosis
7%
Gastroenteritis
7%
Pelvic venous thrombosis
7%
Mouth ulceration
7%
Rectal haemorrhage
7%
Influenza like illness
7%
Nasopharyngitis
7%
Cystitis
7%
Humerus fracture
7%
Fall
7%
Vision blurred
7%
Chest discomfort
7%
Clostridium difficile colitis
7%
Limb injury
7%
Anti-glomerular basement membrane antibody positive
7%
Borrelia test positive
7%
Hyperkalaemia
7%
Tendon pain
7%
Post herpetic neuralgia
7%
Menorrhagia
7%
Chronic obstructive pulmonary disease
7%
Dermatitis allergic
7%
Lipoma
7%
Deep vein thrombosis
7%
Cognitive disorder
7%
Dizziness
7%
Headache
7%
Bronchial obstruction
7%
Lymphopenia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety Analysis Set

Trial Design

1Treatment groups
Experimental Treatment
Group I: ImlifidaseExperimental Treatment1 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.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlifidase
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for kidney transplantation, such as Imlifidase, bortezomib, rituximab, and intravenous immunoglobulin (IVIG), work by reducing donor-specific antibodies (DSA) and preventing antibody-mediated rejection (AMR). Imlifidase cleaves IgG antibodies, lowering DSA levels. Bortezomib inhibits proteasomes, reducing plasma cells that produce antibodies. Rituximab targets CD20 on B cells, leading to their depletion. IVIG modulates the immune response and neutralizes pathogenic antibodies. These mechanisms are vital for kidney transplantation patients as they help prevent organ rejection, ensuring better graft survival and function.
Refractory lupus nephritis: When, why and how to treat.Treatment of idiopathic membranous nephropathy.

Find a Location

Who is running the clinical trial?

Hansa Biopharma ABLead Sponsor
19 Previous Clinical Trials
789 Total Patients Enrolled
Clinical OperationsStudy DirectorHansa Biopharma AB
19 Previous Clinical Trials
2,308 Total Patients Enrolled

Media Library

Imlifidase (Enzyme) Clinical Trial Eligibility Overview. Trial Name: NCT05049850 — Phase 2
Kidney Transplantation Research Study Groups: Imlifidase
Kidney Transplantation Clinical Trial 2023: Imlifidase Highlights & Side Effects. Trial Name: NCT05049850 — Phase 2
Imlifidase (Enzyme) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049850 — Phase 2
~1 spots leftby Oct 2025