A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND EFFICACY OF INTRAVENOUS IDES AFTER ADMINISTRATION OF ASCENDING DOSES IN CHRONIC KIDNEY DISEASE PATIENTS

Hansa Medical AB0 个研究点开始时间: 2014年3月3日最近更新: 2015年10月19日

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•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.

发起方

Hansa Medical AB