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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593421
Recruitment Status : Withdrawn (BioInceptdecided not to pursue this drug target at this time.)
First Posted : July 20, 2018
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
BioIncept LLC
Information provided by (Responsible Party):
Christopher O'Brien, MD, University of Miami

Study Description
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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
Panel Reactive Antibodies 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: open 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
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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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 Name: sPIF
Experimental: synthetic preImplantation factor 2 mg/kg
Patients will be dosed SQ with 14 doses of sPIF
 Drug: synthetic PreImplantation Factor
peptide
Other Name: sPIF
Experimental: synthetic preImplantation factor 3 mg/kg
Patients will be dosed SQ 14 doses
 Drug: synthetic PreImplantation Factor
peptide
Other Name: sPIF
Experimental: synthetic preImplantation factor 4 mg/kg
Patients will be dosed SQ with 14 doses of sPIF
 Drug: synthetic PreImplantation Factor
peptide
Other Name: sPIF
Experimental: synthetic preImplantation factor 5 mg/kg
Patients will be dosed SQ with 14 doses of sPIF
 Drug: synthetic PreImplantation Factor
peptide
Other Name: sPIF


Outcome Measures
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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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 84 days ]
    Determine cPRA levels


Secondary Outcome Measures :
  1. Determine the percentage of patients in remission ass determined by CPRA less than 30% [ Time Frame: 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 [ Time Frame: 6 months post study drug treatment ]
    Determine number of patients eligible for kidney transplant


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593421


Sponsors and Collaborators
Christopher O'Brien, MD
BioIncept LLC
Investigators
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Principal Investigator: eytan barnea, MD BioIncept LLC
More Information
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Publications:

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Responsible Party: Christopher O'Brien, MD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03593421    
Other Study ID Numbers: 20171060
sPIF-US-PRA-001 ( Other Identifier: University of Miami )
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No