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

NCT03593421 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-01-03

No results posted yet for this study

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

Interventions

DRUG

synthetic PreImplantation Factor

peptide

Sponsors & Collaborators

  • BioIncept LLC

    collaborator INDUSTRY

  • Christopher O'Brien, MD

    lead OTHER

Principal Investigators

  • eytan barnea, MD · BioIncept LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-12-01
Completion
2020-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593421 on ClinicalTrials.gov