A study investigating the efficacy and safety of imlifidase in eliminating donor specific antibodies in the treatment of antibody-mediated rejection in kidney Transplant patients
- Conditions
- Antibody-mediated rejection in kidney transplant patientsMedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disordersTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2018-000022-66-AT
- Lead Sponsor
- Hansa Biopharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
1. Signed Informed Consent obtained before any study-related procedures
2. Willingness and ability to comply with the protocol
3. Male and/or female donor kidney recipients age =18 years at the time of screening
4. Presence of DSA(s)
5. Meet the Banff 2017 criteria for active or chronic active AMR
6. At least 25% rise in serum creatinine compared to last individual value taken prior to the AMR. Patients with delayed graft function and AMR within 10 days after transplant (confirmed by kidney biopsy) can be included regardless of serum creatinine level
7. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as:
• combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, transdermal
• progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system (IUS)
• bilateral tubal occlusion
• vasectomised partner
• true abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception]
8. Men willing to use double-barrier contraception from the first day of treatment until at least 2 months after the dose of imlifidase, if not abstinent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Previous treatment with imlifidase
2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
3. Lactating or pregnant females
4. Significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
5. Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion
6. Clinically relevant active infection(s) as judged by the investigator
7. Any condition that in the opinion of the investigator could increase the subject’s risk by participating in the study such as severe immune deficiency and severe cardiac insufficiency (New York Heart Association (NYHA) Class IV) or severe uncontrolled heart disease
8. Known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients
9. Patient unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator
10. Unsuitable to participate in the study for any other reason as judged by the investigator
11. Positive PCR test for SARS-CoV-2 virus infection
12. Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Investigate the efficacy of imlifidase compared with PE in removal of DSA in patients who are experiencing an active AMR episode after kidney transplantation;Secondary Objective: • Evaluate DSA levels up to 180 days after treatment<br>• Evaluate HLA-antibodies levels up to 180 days after treatment<br>• Evaluate the overall kidney function up to 180 days after treatment<br>• Investigate the occurrence of AMR up to 180 days after treatment<br>• Investigate the safety and tolerability of imlifidase compared to PE in patients experiencing active AMR episodes<br>• Evaluate the number of PE-sessions needed<br>• Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of imlifidase<br>;Primary end point(s): Maximum reduction in mean DSA level at any time point during the 5 days following the start of treatment ;Timepoint(s) of evaluation of this end point: • DSA levels will be evaluated pre-dose, at 2, 6, 24, 48, 72, and 96 hours
- Secondary Outcome Measures
Name Time Method