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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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 4 hours before imlifidase dose until day 10
Awards & highlights
Study Summary
This trial will test whether a combination of drugs can reduce DSA and AMR in patients with chronic kidney disease who have a positive crossmatch towards their living donor.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with DSA rebound
Secondary outcome measures
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%
Diarrhoea
13%
Tinnitus
13%
Urinary tract infection
13%
Hyperglycaemia
13%
Leukopenia
7%
Thrombocytopenia
7%
Arthralgia
7%
Cardiac failure
7%
Tendon pain
7%
Hyperphosphataemia
7%
Muscle spasms
7%
Pelvic venous thrombosis
7%
Thrombophlebitis
7%
Gastroenteritis
7%
Fall
7%
Fatigue
7%
Blood iron decreased
7%
Clostridium difficile colitis
7%
Borrelia test positive
7%
Hyperhidrosis
7%
Back pain
7%
Steroid diabetes
7%
Sinus pain
7%
Hyperkalaemia
7%
Ecchymosis
7%
Urticaria
7%
Mouth ulceration
7%
Anti-glomerular basement membrane antibody positive
7%
Haematuria
7%
Rash erythematous
7%
Chest discomfort
7%
Limb injury
7%
Cryoglobulinaemia
7%
Herpes zoster
7%
Nasopharyngitis
7%
Pneumonia
7%
Red blood cell count decreased
7%
Rectal haemorrhage
7%
Pyrexia
7%
Diarrhea
7%
Hypogammaglobulinaemia
7%
Dyspnoea
7%
Clostridium difficile infection
7%
Vision blurred
7%
Pneumonia klebsiella
7%
Humerus fracture
7%
Hypoglycaemia
7%
Influenza like illness
7%
Cystitis
7%
Viral infection
7%
Dehydration
7%
Foreign body sensation in eyes
7%
Decreased appetite
7%
Lipoma
7%
Post herpetic neuralgia
7%
Menorrhagia
7%
Chronic obstructive pulmonary disease
7%
Dermatitis allergic
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
Find a Location
Who is running the clinical trial?
Hansa Biopharma ABLead Sponsor
18 Previous Clinical Trials
786 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigative research currently welcoming participants?
"Unfortunately, this research has already reached its recruitment goal. It was first advertised on October 1st 2022 and the last update to the posting occurred on August 23rd of that same year. However, if you are still looking for other trials, there are currently 3 kidney-related studies and 5 Imlifidase investigations admitting patients into their respective cohorts."
Answered by AI
Has Imlifidase been previously tested in a medical experiment?
"Currently, Imlifidase is the subject of 5 active medical studies with one in Phase 3 trials. These clinical trials span 37 locations across America, including New york City."
Answered by AI
What is the scope of individuals being treated in this trial?
"At this time, enrollment for the trial has been paused. It was originally posted on October 1st 2022 and most recently revised on August 23rd 2022. Currently there are 3 studies involving kidney diseases recruiting patients, as well as 5 trials that require Imlifidase participants."
Answered by AI
How perilous is the administration of Imlifidase to human subjects?
"Imlifidase has been assessed as a 2 on the 1-3 scale due to limited evidence of efficacy; however, there is some clinical data that suggests it is relatively safe."
Answered by AI
Is it possible to enroll in this experiment?
"Qualifying applicants must possess renal organs and be between the ages of 18-70. This trial intends to admit a maximum of 12 individuals."
Answered by AI
What medical conditions are commonly treated with Imlifidase?
"Imlifidase may be employed to manage kidney desensitization and transplantation."
Answered by AI
Does this experiment include elderly participants?
"This medical evaluation is looking to include participants aged 18 or over, but under 70."
Answered by AI
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