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Enzyme

Imlifidase for Kidney Transplant Rejection

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

Study 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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment
Secondary outcome measures
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%
Diarrhoea
13%
Tinnitus
13%
Urinary tract infection
13%
Hyperglycaemia
13%
Leukopenia
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%
Thrombocytopenia
7%
Red blood cell count decreased
7%
Rectal haemorrhage
7%
Pyrexia
7%
Cardiac failure
7%
Arthralgia
7%
Tendon pain
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

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

Who is running the clinical trial?

Hansa Biopharma ABLead Sponsor
18 Previous Clinical Trials
759 Total Patients Enrolled
Elisabeth Sonesson, PhDStudy DirectorHansa Biopharma AB
3 Previous Clinical Trials
50 Total Patients Enrolled
Clinical OperationsStudy DirectorHansa Biopharma AB
19 Previous Clinical Trials
2,281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant recruitment rate for this research project?

"Currently, enrolment for this medical trial is closed; it was first published on April 30th 2019 and last updated November 16th 2022. However, there are currently 30 clinical trials enrolling patients with rejection; transplant kidney issues as well as 5 studies in need of participants studying Imlifidase."

Answered by AI

Is Imlifidase an acceptable risk for patients considering its therapeutic effects?

"While there is evidence of Imlifidase's safety, its efficacy still needs to be evaluated. Consequently, we have assigned it a score of 2 on our scale from 1-3."

Answered by AI

Is there capacity for additional participants in this research endeavor?

"This particular study, posted on April 30th 2019 and last updated November 16th 2022, is not currently enrolling patients. However, 35 other clinical trials are actively recruiting participants for their research studies."

Answered by AI

Have any additional experiments been conducted surrounding Imlifidase?

"At present, 5 trials exploring Imlifidase are live with 1 in Phase 3. These clinical studies have 37 locations spread across the United States, most notably New york City."

Answered by AI

What clinical conditions is Imlifidase typically administered for?

"Imlifidase has been demonstrated to be a useful intervention for desensitizing kidneys prior to transplantation."

Answered by AI

What is the current geographic scope of this research endeavor?

"This clinical trial is being hosted at the Brigham and Women Hospital in Boston, Mayo Clinic in Rochester, and Cedars-Sinai Medical Center in Los Angeles. Additionally it will be conducted out of 4 other medical sites as well."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
2019. "An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03897205.
~5 spots leftby Apr 2025
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