Clinical trial NCT03593421: Phase 2 Dose Finding sPIF in Patients With High Panel Reactive Antibodies
Official title: Phase II, Open Label Adaptive Design Dose Finding Study to Investigate Effect of Synthetic PreImplantation Factor (sPIF) in Patients With High Panel Reactive Antibodies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Panel Reactive Antibodies
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: BioIncept LLC
First posted: 2018-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: open label, adaptive design, dose finding study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Outpatient male and females 18-75 years old
* Able and willing to give written informed consent and comply with the requirements of the study protocol
* Calculated panel reactive antibody (cPRA) \>30% and \<60% with a threshold using mean fluorescent intensity (MFI) of 3,000 or standard fluorescence intensity (SFI) of 60,000 over six months.
* Women who are of childbearing potential must have a negative serum pregnancy test prior to being enrolled in the study and agree to use effective method of contraception throughout the 84-day study.
* Patients on kidney dialysis 3.3 Exclusion Criteria
* Patients not capable of following through the treatment for various reasons as determined by treating physicians
* Pregnant females
* Requiring blood transfusions
* Have an active infection
* Infection with hepatitis C virus (HCV) or hepatitis B virus(HBV) or human immunodeficiency virus (HIV), lack of documentation of treatment of a positive PPD, baseline leukopenia, white blood cell count (WBC) \<4.0, thrombocytopenia (platelet count \<100,000/mm) or difficult to treat anemia, a hematocrit chronically \<25% on intravenous iron and EPO (erythropoietin) therapy
* Active cancer within 5 years
* Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

Primary outcomes:
measure: 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
timeFrame: 84 days
measure: Evaluate the pharmacokinetics of sPIF levels in the circulation after multiple ascending, subcutaneously administered doses of sPIF by measurement of sPIF in circulation
timeFrame: 84 days
measure: Evaluate the effect of sPIF on serum cPRA following administration of multiple ascending, subcutaneously administered doses as determined by CPRA levels
timeFrame: 84 days
Secondary outcomes:
measure: Determine the percentage of patients in remission ass determined by CPRA less than 30%
timeFrame: 84 days
measure: Assess number of patients receiving a kidney transplant within 6 months post-day 84 as dertermined by patients being available for kidney transplant
timeFrame: 6 months post study drug treatment
Other outcomes:
Locations:
Study officials:
affiliation: BioIncept LLC
name: eytan barnea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnea ER, Rambaldi M, Paidas MJ, Mecacci F. Reproduction and autoimmune disease: important translational implications from embryo-maternal interaction. Immunotherapy. 2013 Jul;5(7):769-80. doi: 10.2217/imt.13.59.