Imlifidase for Kidney Transplantation in Highly Sensitized Patients

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Kidney Transplantation in Highly Sensitized PatientsImlifidase - Drug
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new treatment can help kidney transplant patients with high levels of antibodies to get a kidney from a deceased donor.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: From signing informed consent to 12 months

12 months after randomization
Frequency of dialysis dependency at 12 months
Frequency of wait-list categories at 12 months
Graft failure-free survival at 12 months
Graft survival at 12 months
Mean estimated glomerular filtration rate (eGFR) at 12 months
Patient survival at 12 months
Month 12
Change in patient-reported life participation, as measured by PROMIS-SF-8a
Month 12
Antibody-mediated rejection (AMR) frequency
Cell-mediated rejection (CMR) frequency
Month 12
Safety as measured by adverse events (AEs)
Safety as measured by other adverse events (AEs)
Safety as measured by serious adverse events (SAEs)
Month 1
Donor specific antibody (DSA) levels for all antibodies with a mean fluorescence intensity (MFI) of ≥1000
Month 1
Anti-drug antibodies (ADA)
Day 10
Imlifidase pharmacodynamics
Day 15
Imlifidase pharmacokinetics (AUC)
Imlifidase pharmacokinetics (CL)
Imlifidase pharmacokinetics (Cmax)
Imlifidase pharmacokinetics (Vz)
Imlifidase pharmacokinetics (t1/2)
Imlifidase pharmacokinetics (tmax)
Hour 4
Conversion of positive crossmatch test to negative
Day 7
Frequency of delayed graft function

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Safety Analysis Set
40%Anaemia
27%Nausea
20%Hypertension
13%Tinnitus
13%Diarrhoea
13%Hyperglycaemia
13%Vomiting
13%Urinary tract infection
13%Leukopenia
7%Bronchial obstruction
7%Dermatitis allergic
7%Borrelia test positive
7%Diarrhea
7%Pyrexia
7%Foreign body sensation in eyes
7%Pneumonia klebsiella
7%Clostridium difficile infection
7%Viral infection
7%Pneumonia
7%Dehydration
7%Cardiac failure
7%Cryoglobulinaemia
7%Back pain
7%Muscle spasms
7%Cognitive disorder
7%Haematuria
7%Hypogammaglobulinaemia
7%Arthralgia
7%Fatigue
7%Herpes zoster
7%Red blood cell count decreased
7%Blood iron decreased
7%Hyperphosphataemia
7%Anti-glomerular basement membrane antibody positive
7%Decreased appetite
7%Dizziness
7%Ecchymosis
7%Steroid diabetes
7%Urticaria
7%Hyperhidrosis
7%Pelvic venous thrombosis
7%Chest discomfort
7%Tendon pain
7%Rash erythematous
7%Headache
7%Lymphopenia
7%Menorrhagia
7%Dyspnoea
7%Mouth ulceration
7%Cystitis
7%Gastroenteritis
7%Fall
7%Nasopharyngitis
7%Thrombophlebitis
7%Sinus pain
7%Thrombocytopenia
7%Influenza like illness
7%Vision blurred
7%Limb injury
7%Rectal haemorrhage
7%Humerus fracture
7%Clostridium difficile colitis
7%Hypoglycaemia
7%Hyperkalaemia
7%Lipoma
7%Post herpetic neuralgia
7%Chronic obstructive pulmonary disease
7%Deep vein thrombosis
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT03157037) in the Safety Analysis Set ARM group. Side effects include: Anaemia with 40%, Nausea with 27%, Hypertension with 20%, Tinnitus with 13%, Diarrhoea with 13%.

Trial Design

1 Treatment Group

Imlifidase
1 of 1

Experimental Treatment

64 Total Participants · 1 Treatment Group

Primary Treatment: Imlifidase · No Placebo Group · Phase 3

Imlifidase
Drug
Experimental Group · 1 Intervention: Imlifidase · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imlifidase
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from signing informed consent to 12 months

Who is running the clinical trial?

Hansa Biopharma ABLead Sponsor
14 Previous Clinical Trials
516 Total Patients Enrolled
2 Trials studying Kidney Transplantation in Highly Sensitized Patients
237 Patients Enrolled for Kidney Transplantation in Highly Sensitized Patients
Lina HallbergStudy DirectorHansa Biopharma AB
Clinical OperationsStudy DirectorHansa Biopharma AB
15 Previous Clinical Trials
1,081 Total Patients Enrolled
2 Trials studying Kidney Transplantation in Highly Sensitized Patients
237 Patients Enrolled for Kidney Transplantation in Highly Sensitized Patients

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
in 58 of 58 patients The original text says that the calculated panel reactive antibody (cPRA) was ≥99.9% in 58 of 58 patients.
are performed Before any trial-related procedures are performed, you will be asked to sign an informed consent form
Male or female between the ages of 18 and 70 years old who are participating in the screening.
Chronic kidney disease is a stage 5 condition that is considered highly sensitized by standard selection criteria
for a given patient, has been found to be more accurate than traditional crossmatch (TM) using serological methods
The willingness and ability to comply with the protocol is important in order to ensure the validity and reliability of the study.
People who are willing to participate in the planned 4-year extension trial are people who want to continue to receive the study drug.