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

NCT03593421 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 20171060sPIF-US-PRA-001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panel Reactive Antibodies

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  84 days

Secondary Outcomes (2)

• Determine the percentage of patients in remission ass determined by CPRA less than 30%

  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

  6 months post study drug treatment

Study Arms (5)

synthetic preImplantation factor 1 mg/kg

EXPERIMENTAL

Patients will be dosed SQ with 14 doses of sPIF

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 2 mg/kg

EXPERIMENTAL

Patients will be dosed SQ with 14 doses of sPIF

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 3 mg/kg

EXPERIMENTAL

Patients will be dosed SQ 14 doses

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 4 mg/kg

EXPERIMENTAL

Patients will be dosed SQ with 14 doses of sPIF

Drug: synthetic PreImplantation Factor

synthetic preImplantation factor 5 mg/kg

EXPERIMENTAL

Patients will be dosed SQ with 14 doses of sPIF

Drug: synthetic PreImplantation Factor

Interventions

synthetic PreImplantation Factor DRUG

peptide

Also known as: sPIF

synthetic preImplantation factor 1 mg/kg; synthetic preImplantation factor 2 mg/kg; synthetic preImplantation factor 3 mg/kg; synthetic preImplantation factor 4 mg/kg; synthetic preImplantation factor 5 mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Christopher O'Brien, MD: lead
• BioIncept LLC: collaborator

Related Publications (1)

• 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.

  PMID: 23829627 BACKGROUND

MeSH Terms

Interventions

preimplantation factor, synthetic

Study Officials

• eytan barnea, MD

  BioIncept LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: open label, adaptive design, dose finding study

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 20, 2018
• Study Start: February 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: January 3, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share