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

NCT ID: NCT03593421

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Panel Reactive Antibodies

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

synthetic preImplantation factor 1 mg/kg

Patients will be dosed SQ with 14 doses of sPIF

Group Type: EXPERIMENTAL

synthetic PreImplantation Factor

Intervention Type: DRUG

peptide

synthetic preImplantation factor 2 mg/kg

Patients will be dosed SQ with 14 doses of sPIF

Group Type: EXPERIMENTAL

synthetic PreImplantation Factor

Intervention Type: DRUG

peptide

synthetic preImplantation factor 3 mg/kg

Patients will be dosed SQ 14 doses

Group Type: EXPERIMENTAL

synthetic PreImplantation Factor

Intervention Type: DRUG

peptide

synthetic preImplantation factor 4 mg/kg

Patients will be dosed SQ with 14 doses of sPIF

Group Type: EXPERIMENTAL

synthetic PreImplantation Factor

Intervention Type: DRUG

peptide

synthetic preImplantation factor 5 mg/kg

Patients will be dosed SQ with 14 doses of sPIF

Group Type: EXPERIMENTAL

synthetic PreImplantation Factor

Intervention Type: DRUG

peptide

Interventions

synthetic PreImplantation Factor

peptide

Intervention Type: DRUG

Other Intervention Names

sPIF

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.

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioIncept LLC

INDUSTRY

Sponsor Role: collaborator

Christopher O'Brien, MD

OTHER

Sponsor Role: lead

Responsible Party

Christopher O'Brien, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

eytan barnea, MD

Role: PRINCIPAL_INVESTIGATOR

BioIncept LLC

References

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.

Reference Type: BACKGROUND

PMID: 23829627 (View on PubMed)

Other Identifiers

sPIF-US-PRA-001

Identifier Type: OTHER

Identifier Source: secondary_id

20171060

Identifier Type: -

Identifier Source: org_study_id