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Phase 2 Dose Finding sPIF in Patients With High Panel Reactive Antibodies

Sponsor
Christopher O'Brien, MD (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03593421
Collaborator
BioIncept LLC (Industry)
0
Enrollment
5
Arms
23
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: synthetic PreImplantation Factor
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
open label, adaptive design, dose finding studyopen label, adaptive design, dose finding study
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: synthetic preImplantation factor 1 mg/kg

Patients will be dosed SQ with 14 doses of sPIF

Drug: synthetic PreImplantation Factor
peptide
Other Names:
  • sPIF

    		•
    Experimental: synthetic preImplantation factor 2 mg/kg

    Patients will be dosed SQ with 14 doses of sPIF

    Drug: synthetic PreImplantation Factor
    peptide
    Other Names:
  • sPIF

    		•
    Experimental: synthetic preImplantation factor 3 mg/kg

    Patients will be dosed SQ 14 doses

    Drug: synthetic PreImplantation Factor
    peptide
    Other Names:
  • sPIF

    		•
    Experimental: synthetic preImplantation factor 4 mg/kg

    Patients will be dosed SQ with 14 doses of sPIF

    Drug: synthetic PreImplantation Factor
    peptide
    Other Names:
  • sPIF

    		•
    Experimental: synthetic preImplantation factor 5 mg/kg

    Patients will be dosed SQ with 14 doses of sPIF

    Drug: synthetic PreImplantation Factor
    peptide
    Other Names:
  • sPIF

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [84 days]

      No grade SAE > Grade 3

    2. Evaluate the pharmacokinetics of sPIF levels in the circulation after multiple ascending, subcutaneously administered doses of sPIF by measurement of sPIF in circulation [84 days]

      sPIF circulating levels are assessed following dialysis and post-first injection at 1, 2, and 4 hours and before last sPIF dose, trough values.

    3. Evaluate the effect of sPIF on serum cPRA following administration of multiple ascending, subcutaneously administered doses as determined by CPRA levels [84 days]

      Determine cPRA levels

    Secondary Outcome Measures

    1. Determine the percentage of patients in remission ass determined by CPRA less than 30% [84 days]

      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.

    2. Assess number of patients receiving a kidney transplant within 6 months post-day 84 as dertermined by patients being available for kidney transplant [6 months post study drug treatment]

      Determine number of patients eligible for kidney transplant

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Christopher O'Brien, MD
    • BioIncept LLC

    Investigators

    • Principal Investigator: eytan barnea, MD, BioIncept LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Christopher O'Brien, MD, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT03593421
    Other Study ID Numbers:
    • 20171060
    • sPIF-US-PRA-001
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Jan 3, 2019
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 3, 2019