Phase 2
N=8
Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02224820 ↗Enrolled (actual)
8
Serious AEs
50.0%
Results posted
May 2016
Primary outcome: Primary: Efficacy — 372 MFI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IdeS (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hansa Biopharma AB
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy |
372 | — |
| SECONDARY Safety |
76 | — |
| SECONDARY Pharmacodynamics |
30 | — |
| SECONDARY Immunogenicity |
8 | — |
| SECONDARY Pharmacokinetics |
5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with chronic kidney disease and in dialysis with identified antibodies against at least two HLA antigens of which at least one is 3000 MFI or more as measured by SAB assay on at least two occasions.
Exclusion Criteria
- Prior malignancy within 2 years excluding adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ and prostate cancer Gleason New York Heart Association (NYHA) grade 3, unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD)
- History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g streptokinase and/or staphylokinase)
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 4 months of the first administration of investigational product in this study. Patients consented and screened but not dosed in previous studies are not excluded
Data sourced from ClinicalTrials.gov (NCT02224820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.