IdeS is an immunoglobulin g (IgG) cleaving enzyme. It will given to patients with donor specific antibodies to reduce the antibody load and thus enable kidney transplantation. IdeS antibody reducing efficacy and its safety will be studied.
Study 13-HMedIdeS-02 (EudraCT no. 2013-005417-13) is a single centre, single arm, dose finding, Phase II study in sensitized CKD patients assessing safety, tolerability, pharmacokinetics (PK) and efficacy of HMED-IdeS without intent to transplantation. However, patients are not removed from the transplant waitlist during the study. Included patients has a panel reactive antibody \[PRA\] \>70% (n=7).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Doses are administered in ascending doses
Dept. of Transplant Surgery, Uppsala University Hospital
Uppsala, Sweden
Efficacy
Efficacy was defined as the IdeS dosing scheme in the majority of the patients resulting in human leucocyte antigen (HLA) antibody levels which are acceptable for transplantation, measured as mean fluorescent intensity (MFI) of less than 1100, within 24 hours from dosing. MFI was determined by single antigen bead (SAB) assay and detection of complement fixating ability (CIq Screen) in serum.
Time frame: 24 hours
Safety
Adverse events (all clinical laboratory tests, vital signs and ECG jugded as clinically significant were reported as AEs)
Time frame: 9 weeks
Pharmacodynamics
IgG cleavage and regeneration measured by ELISA
Time frame: Up to day 64
Immunogenicity
Presence of Anti-Drug Antibodies formation in serum throughout a 64 day period
Time frame: Up to 64 days
Pharmacokinetics
IdeS T1/2 in alpha phase. One patient who interrupted dose was excluded.
Time frame: Up to 21 days
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