A STUDY TO EVALUATE THE SAFETY AND EFFICACY OF IDES IN CHRONIC KIDNEY DISEASE PATIENTS
- Conditions
- Chronic kidney disease (CKD) stage 5 and on waiting list for renal transplantationTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2013-005417-13-SE
- Lead Sponsor
- Hansa Medical AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Age 18 years or above
Diagnosed with CKD 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.
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
1. Tested positive for IgE antibodies against IdeS
2. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
3. Clinical signs of ongoing infectious disease.
4. Patients who have had their spleen removed
5.Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
6. Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
7.Patients with an ongoing relapse in an autoimmune disease. However, patients with diabetes or IgA-nephritis will not be excluded from the study
8.Patients who have undergone liver-, heart- or lungtransplantation
9. Patients that have received cell transplantation or cell therapy within 5 years.
10. Patients who have previously been treated with biological therapies based on antibodies within at least 5 T½ of the drug.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To find an IdeS dosing scheme which in the majority of the patients results in HLA antibody levels which are acceptable for transplantation. This will be measured as an MFI less than 1100 as measured in a single antigen bead (SAB) assay, within 24 hours from dosing <br>;Secondary Objective: To determine the following in CKD patients:<br>1. Cytotoxic sera screen<br>2. FACS crossmatch test against available donor cells<br>3. The safety and tolerability of IdeS <br>4. The pharmacokinetic (PK) profile of IdeS <br>5. Pharmacodynamic (PD) profile of IdeS (cleavage of IgG)<br>6. The immunogenicity profile of IdeS<br>;Primary end point(s): Efficacy defined as the IdeS dosing scheme resulting in HLA antibody levels which are acceptable for transplantation, measured as an MFI of less than 1100 as measured in an SAB assay, within 24 hours from dosing;Timepoint(s) of evaluation of this end point: 1, 2, and 24 hours, 64 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Reduction of PRA levels in cytotoxic sera screen after IdeS treatment (efficacy)<br>Result in FACS crossmatch test against available donor cells after IdeS treatment (efficacy)<br>Safety parameters (Adverse events, clinical laboratory tests, vital signs and ECGs)<br>Pharmacokinetic (PK) profile of IdeS<br>Pharmacodynamic (PD) profile of IdeS (cleavage of IgG)<br>•Immunogenicity of IdeS by measuring anti drug antibodies (ADA)<br>;Timepoint(s) of evaluation of this end point: Efficacy up to and including 24 hours after dosing<br>PK up to and including 21 days<br>PD up to and including 64 days<br>ADA until day 365