NCT03593421

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

Phase II, Open Label Adaptive Design Dose Finding Study to Investigate Effect of Synthetic PreImplantation Factor (sPIF) in Patients With High Panel Reactive Antibodies

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Christopher O'Brien, MD · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	synthetic PreImplantation Factor	peptide

Timeline

• Start date: 2019-02-01
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2018-07-20
• Last updated: 2019-01-03

Regulatory

• FDA-regulated drug study