A Phase II Study to Evaluate the Efficacy of IdeS to reduce antibodies in Transplant Patients with a Positive Crossmatch Test
- Conditions
- Chronic Kidney Disease with donor specific antibodies (ASA)Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-002064-13-SE
- Lead Sponsor
- Hansa Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 14
Male or female age 18-70 years at the time of screening
Patients on the kidney transplant waitlist who have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely.
Patients with a live or deceased donor with a positive crossmatch test.
Patient must be able to understand and sign the informed consent
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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Previous treatment with IdeS
Previous high dose IVIg treatment (2 g/kg BW) within 28 days prior to IdeS treatment
Lactating or pregnant females, women of child-bearing age who are not willing or able to practice FDA-approved forms of contraception
HIV-positive patients
Patients with HBV infection or HCV infection
Patients with active tuberculosis
A significantly abnormal general serum screening lab result according to the investigator’s judgement.
Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure, unstable coronary disease or oxygen dependent COPD
Patients with active CMV or EBV infection
Patients with a history of major thrombotic events, patients with active peripheral vascular disease or patients with proven hypercoagulable conditions
Allergy/sensivity to IdeS infusions
Patients who have a live donor and test positive for ImmunoCAP anti-IdeS IgE
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To asses the IdeS efficacy in creating a negative crossmatch test;Secondary Objective: To determine DSA levels at multiple times <br>To determine time to creating a negative CDC crossmatch test<br>To determine time to creating a negative FACS crossmatch test<br>To evaluate safety parameters <br>To monitor kidney function after IdeS treatment<br>To establish the pharmacokinetic (PK) profile of IdeS<br>To establish the pharmacodynamic (PD) profile of IdeS <br>To establish the immunogenicity profile (ADA) of IdeS ;Primary end point(s): Efficacy defined as IdeS ability to create a negative crossmatch test within 24 hours after IdeS dosing;Timepoint(s) of evaluation of this end point: Within 24 hours after IdeS dosing
- Secondary Outcome Measures
Name Time Method