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

Phase 2 Withdrawn Christopher O'Brien, MD BioIncept LLC · collab

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2019-02-01
Primary completion: 2020-12-01
Completion: 2020-12-31

Outcome

Outcome not reported

Stopped: “BioInceptdecided not to pursue this drug target at this time.”

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Synthetic PreImplantation Factor	Peptide	1 mg/kg	Subcutaneous
Subject	Synthetic PreImplantation Factor	Peptide	2 mg/kg	Subcutaneous
Subject	Synthetic PreImplantation Factor	Peptide	3 mg/kg	Subcutaneous
Subject	Synthetic PreImplantation Factor	Peptide	4 mg/kg	Subcutaneous
Subject	Synthetic PreImplantation Factor	Peptide	5 mg/kg	Subcutaneous

Indications

No indication recorded.