What side effects are associated with this type of intervention?

Common treatments for kidney transplantation, such as bortezomib, belatacept, rituximab, and intravenous immunoglobulin (IVIG), have various side effects. Bortezomib can cause peripheral neuropathy, gastrointestinal symptoms, and hematologic toxicities. Belatacept may lead to an increased risk of infections and post-transplant lymphoproliferative disorder (PTLD). Rituximab is associated with infusion reactions, infections, and potential reactivation of hepatitis B. IVIG can cause headaches, fever, chills, and, rarely, thromboembolic events and renal dysfunction. These side effects should be carefully managed in patients undergoing kidney transplantation.

What prior FDA approvals exist?

FDA-approved treatments for kidney transplantation that are similar to Imlifidase include drugs like Rituximab, which targets CD20 on B cells to reduce antibody production, and intravenous immunoglobulin (IVIG), which modulates the immune response and can help reduce donor-specific antibodies. Additionally, Bortezomib, a proteasome inhibitor, has been used to deplete plasma cells that produce antibodies. These treatments aim to prevent antibody-mediated rejection by targeting different components of the immune system involved in the production and activity of donor-specific antibodies.

What other types of research exist?

Promising novel alternatives to Imlifidase for kidney transplantation patients include bortezomib, belatacept, rituximab, and IVIg. These agents are used in combination with Imlifidase to suppress donor-specific antibodies and prevent antibody-mediated rejection. Additionally, emerging therapies and ongoing clinical trials may provide new options in the near future.

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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

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 hours before imlifidase dose until day 15

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

Diarrhea

Back pain

Decreased appetite

Haematuria

Pyrexia

Viral infection

Pneumonia

Dehydration

Muscle spasms

Sinus pain

Cardiac failure

Hypogammaglobulinaemia

Blood iron decreased

Pneumonia klebsiella

Foreign body sensation in eyes

Fatigue

Herpes zoster

Hyperphosphataemia

Thrombophlebitis

Thrombocytopenia

Cryoglobulinaemia

Clostridium difficile infection

Red blood cell count decreased

Hypoglycaemia

Steroid diabetes

Rash erythematous

Urticaria

Arthralgia

Ecchymosis

Dyspnoea

Hyperhidrosis

Gastroenteritis

Pelvic venous thrombosis

Mouth ulceration

Rectal haemorrhage

Influenza like illness

Nasopharyngitis

Cystitis

Humerus fracture

Fall

Vision blurred

Chest discomfort

Clostridium difficile colitis

Limb injury

Anti-glomerular basement membrane antibody positive

Borrelia test positive

Hyperkalaemia

Tendon pain

Post herpetic neuralgia

Menorrhagia

Chronic obstructive pulmonary disease

Dermatitis allergic

Lipoma

Deep vein thrombosis

Cognitive disorder

Dizziness

Headache

Bronchial obstruction

Lymphopenia

100%

80%

60%

40%

20%

Study treatment Arm

Safety Analysis Set

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

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.

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