A Phase II Study to Evaluate the Efficacy of IdeS to reduce antibodies in Transplant Patients with a Positive Crossmatch Test

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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. The breadth and strength of sensitization will predict an extremely low likelihood of successful desensitization or kidney paired donation. For Sweden eligible patients must fulfil the criteria to be listed on the Scandia Transplant Acceptable Mismatch Program (STAMP) - on transplantation waiting list more than 1 year - HLA antibody status with PRA more than or equal to 80% based on CDC and/or solid phase assay - HLA status confirmed by two consecutive samples over a period of more than 3 months - proven reactivity against HLA class I or II andtigens or both - last tested sample drawn less than 3 months before acceptande
Patients with a medically acceptable live donor are eligible if they fulfil the criteria to be listed on the Scandinavian Transplant Kidney Exchange Program (STEP) - recipient with donor specific antibodies - positive crossmatch between recipient and live donor.
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

Exclusion Criteria

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. European centers will follow guidelines issued by EMAs Clinical Trial Facilitation Group (CTFG) 2014-09-15 as follows:
a - combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: i/ oral - ii/intravaginal - iii/ transdermal
b. - progesterone-only hormonal contraception associated with inhibition of ovulation: i/oral - ii/ injectable
c. - vasectomized partner provided that partner is the sole sexual partner of the trial participant and that the vasecomized partner has received medical assessment of the surgical success.
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 clinically significant thrombotic episodes, and patients with active peripheral vascular disease
Allergy/sensivity to any of the ingredients of IMP
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

Secondary Outcome Measures

Name	Time	Method

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