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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 weeks3 visits

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

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

Diarrhea

Back pain

Decreased appetite

Haematuria

Pyrexia

Viral infection

Pneumonia

Dehydration

Muscle spasms

Sinus pain

Cardiac failure

Hypogammaglobulinaemia

Blood iron decreased

Pneumonia klebsiella

Foreign body sensation in eyes

Fatigue

Herpes zoster

Hyperphosphataemia

Thrombophlebitis

Thrombocytopenia

Cryoglobulinaemia

Clostridium difficile infection

Red blood cell count decreased

Hypoglycaemia

Steroid diabetes

Rash erythematous

Urticaria

Arthralgia

Ecchymosis

Dyspnoea

Hyperhidrosis

Gastroenteritis

Pelvic venous thrombosis

Mouth ulceration

Rectal haemorrhage

Influenza like illness

Nasopharyngitis

Cystitis

Humerus fracture

Fall

Vision blurred

Chest discomfort

Clostridium difficile colitis

Limb injury

Anti-glomerular basement membrane antibody positive

Borrelia test positive

Hyperkalaemia

Tendon pain

Post herpetic neuralgia

Menorrhagia

Chronic obstructive pulmonary disease

Dermatitis allergic

Lipoma

Deep vein thrombosis

Cognitive disorder

Dizziness

Headache

Bronchial obstruction

Lymphopenia

100%

80%

60%

40%

20%

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

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