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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02224820 |
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Date of registration:
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15/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Study, Evaluation of Safety and Efficacy of IdeS in Chronic Kidney Disease
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Scientific title:
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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 |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02224820 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Tomas Lorant, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University Hospital |
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Key inclusion & exclusion criteria
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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 <6 and
prostate-specific antigen (PSA) <10 ng/mL.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C
antibody and human immunodeficiency virus (HIV
- Clinical signs of ongoing infectious disease.
- Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure
> 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Intervention(s)
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Biological: IdeS
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Primary Outcome(s)
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Efficacy
[Time Frame: 24 hours]
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Secondary Outcome(s)
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Pharmacodynamics
[Time Frame: Up to day 64]
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Immunogenicity
[Time Frame: Up to 64 days]
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Pharmacokinetics
[Time Frame: Up to 21 days]
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Safety
[Time Frame: 9 weeks]
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Secondary ID(s)
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2013-005417-13
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13-HMedIdeS-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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