This is an open labeled dose finding adaptive design study. Patients with elevated cPRA values, 30-60% will be recruited and administered sPIF injected subcutaneously for 14 doses; one dose on Monday, Wednesday, Friday, or Tuesday, Thursday, Saturday, per individual patient dialysis schedule.
The purpose of this study is to determine the sPIF dose that reduces serum cPRA to \<30%, when administered 14 doses. Safety, tolerability, and efficacy will be evaluated at day 42 and and day 84. The suitability of a patient to receive a kidney transplant will also be monitored up to 6 months after Day 84. Safety and tolerability will be assessed at each of the increased doses and throughout the treatment duration. Exploratory analysis of blood indices will be carried out and changes based on history, physical and laboratory exams will be assessed according to the 12 systems.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
peptide
Evaluate the safety and tolerability of multiple ascending, subcutaneously administered doses of sPIF in patients with high panel reactive antibodies (PRA) with no SAEs greater than grade 3
No grade SAE \> Grade 3
Time frame: 84 days
Evaluate the pharmacokinetics of sPIF levels in the circulation after multiple ascending, subcutaneously administered doses of sPIF by measurement of sPIF in circulation
sPIF circulating levels are assessed following dialysis and post-first injection at 1, 2, and 4 hours and before last sPIF dose, trough values.
Time frame: 84 days
Evaluate the effect of sPIF on serum cPRA following administration of multiple ascending, subcutaneously administered doses as determined by CPRA levels
Determine cPRA levels
Time frame: 84 days
Determine the percentage of patients in remission ass determined by CPRA less than 30%
Determine cPRA levels as defined by \<30% until day 42, and sustained until day 84. Analysis is based on decrease in cPRA percent, median fluorescent intensity (MFI) and standard fluorescent intensity (SFI) analysis.
Time frame: 84 days
Assess number of patients receiving a kidney transplant within 6 months post-day 84 as dertermined by patients being available for kidney transplant
Determine number of patients eligible for kidney transplant
Time frame: 6 months post study drug treatment
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