A Phase Ib, Open-Label, Single Arm Study to Assess the Safety, Pharmacokinetics, and Impact on Humoral Sensitization of SANGUINATE Infusion in Patients with End Stage Renal Disease (ESRD).
The purpose of the study is to investigate the safety of SANGUINATE on humoral sensitization in End Stage Renal Disease (ESRD) patients receiving dialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Single two-hour infusion of SANGUINATE
University of Cincinnati/ Division of Nephrology
Cincinnati, Ohio, United States
Safety of study treatment as determined by changes in vital signs, electrocardiographic assessments, clinical signs, and bio-analytical measures (e.g., blood chemistry, hematology), and reported adverse events following infusion
Composite endpoint with multiple vital signs, ECGs, clinical assessments and bio-analytical lab measurements over the 90 day time frame.
Time frame: 90 days
Mean change in the number of HLA-Antibody specificities determined by single antigen bead assays
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Time frame: 90 days
Mean change in the overall strength of HLA-Antibody specificities determined by single antigen bead assays
Antibody testing Human leukocyte antigen- antibody (HLA-Ab) HLA Tissue Typing (screening visit only) Calculated Panel Reactive Antibody (CPRA)
Time frame: 90 days
Mean change in the calculated panel reactive antibody (CPRA)
Antibody testing
Time frame: 90 days
Percent of patients with an increase in number of HLA-Ab specificities determined by single antigen bead assays
Antibody testing
Time frame: 90 Days
Percent of patients with an increase in CPRA
Antibody testing
Time frame: 90 Days
Pharmacokinetic profile as determined from blood plasma over time (Tmax, Cmax, AUC, half-life, coefficient of variation, and the apparent elimination rate constant)
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Time frame: 22 Days
Percent of patients with an increase in the overall strength of HLA-Antibodies
Antibody testing
Time frame: 90 Days