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Enzyme

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

Melbourne, Australia
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, day 6, day 8, day 1, and day 15
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether imlifidase is more efficient than plasma exchange at reducing DSA in patients with active or chronic active AMR after a kidney transplant.

See full description

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, day 6, day 8, day 1, and day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, day 6, day 8, day 1, and 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
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment
Secondary study objectives
Concentration of Anti-drug Antibodies (ADAs)
DSA Functionality Determined by C1q Analysis Pre- and Post-treatment
Estimated Glomerular Filtration Rate (eGFR) Levels
+15 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ImlifidaseExperimental Treatment1 Intervention
Subjects randomized to imlifidase treatment received one intravenous dose of imlifidase, 0.25 mg/kg, administered over 15 minutes.
Group II: Plasma ExchangeActive Control1 Intervention
Subjects randomized to plasma exchange (PE) treatment received 5-10 sessions of PE, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlifidase
2017
Completed Phase 2
~80

Find a Location

Closest Location:New York University Grossman School of Medicine· New York, NY

Who is running the clinical trial?

Hansa Biopharma ABLead Sponsor
19 Previous Clinical Trials
754 Total Patients Enrolled
Clinical OperationsStudy DirectorHansa Biopharma AB
19 Previous Clinical Trials
2,273 Total Patients Enrolled
Elisabeth Sonesson, PhDStudy DirectorHansa Biopharma AB
3 Previous Clinical Trials
50 Total Patients Enrolled
~4 spots leftby Mar 2026