ACTRN12624000567527
Not yet recruiting
Phase 2
A Phase II Trial to Evaluate the Safety and Efficacy of clazakizumab for the desensitisation of highly sensitized patients on the deceased donor kidney transplant waiting list
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- End stage kidney disease
- Sponsor
- Royal Melbourne Hospital
- Enrollment
- 10
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age 18\-70 years at the time of screening.
- •2\.Highly sensitized:
- •a.with a cPRA of greater than 98% based on their current unacceptable HLA antigens on the transplant waiting list.
- •b.Must remain highly sensitized with a cPRA greater than 95% after altering unacceptable HLA antigens to only include those to which they have current antibodies detected by Luminex screening with an MFI greater than 1500 or lower if it is an antibody against a repeat HLA mismatch from a previous transplant, if it appears likely that an anti\-HLA antibody is binding multiple different Luminex beads leading to an apparent lowering of the MFI or if a previous surrogate flow cytometric crossmatch was positive due to that antibody.
- •3\.Must have end\-stage kidney disease and currently be active on the deceased donor kidney transplant waiting list for greater than 12 months.
- •4\.Written informed consent obtained from subject (or legally acceptable representative).
Exclusion Criteria
- •1\.Participant is unable or unwilling to comply with study procedures in the opinion of the Investigator.
- •2\.Requiring multi\-organ transplant.
- •3\.Pregnant, breastfeeding, or unwillingness to practice highly effective birth control during the study and for 5 months after last dose of study medication.
- •4\.History of anaphylaxis.
- •5\.Abnormal liver function test (LFTs) (alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/bilirubin greater than 1\.5 times the upper limit of normal) at screening or other significant liver disease.
- •6\.Latent or active tuberculosis:
- •a.Chest X\-ray (CXR) in the past 6 months showing evidence of latent or active tuberculosis. If CXR is not available, it must be performed at screening.
- •b.Positive QuantiFERON\-TB Gold test at screening.
- •7\.Human Immunodeficiency Virus (HIV) positive at screening.
- •8\.Presence of hepatitis B surface antigen (HBsAg) at screening
Outcomes
Primary Outcomes
Not specified
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