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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 belowSelect...
I am between 18 and 70 years old.
Select...
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:Select...
I have a history of blood clotting disorders.
Select...
I have or had a blood disorder called TTP, or it runs in my family.
Select...
I do not have severe heart or lung conditions needing close watch.
Select...
I haven't taken any experimental drugs recently, except for imlifidase.
Select...
I have active tuberculosis.
Select...
I have been treated with imlifidase before.
Select...
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
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 moreSide effects data
From 2020 Phase 2 trial • 15 Patients • NCT0315703740%
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's requirements.I am between 18 and 70 years old.My doctor thinks I shouldn't join the trial for a specific reason.I have a history of blood clotting disorders.I do not have severe heart or lung conditions needing close watch.I have or had a blood disorder called TTP, or it runs in my family.I haven't taken any experimental drugs recently, except for imlifidase.I have active tuberculosis.I have received a high dose of IVIg treatment within the last 28 days.I have been treated with imlifidase before.I show signs of hepatitis B, hepatitis C, CMV, or EBV infection.I am highly sensitized, on the UNOS list for a kidney transplant, with a cPRA ≥ 98%, and have been in a kidney exchange program for over a year.I am on the UNOS waiting list for a kidney transplant with a cPRA of 99.9% or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Imlifidase
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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