NCT02378662

TARGTEPO Treatment for Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)

Safety & Efficacy of Prolonged Physiologic Erythropoietin (EPO) Level Treatment of Anemia in End Stage Renal Disease (ESRD) Patients Undergoing Peritoneal Dialysis (PD)Using MDGN201 TARGTEPO

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment in Peritoneal Dialysis patients

Detailed description

This is a Phase II, open-label study. Each patient will receive targeted dose of Erythropoietin (EPO) delivered via TARGTEPO. The targeted doses will be determined according to 2 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). The objective is to evaluate safety and biologic activity of TARGTEPO treatment when maintaining Hb levels within the target range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline.

Conditions

• Anemia of End Stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MDGN201 TARGTEPO	MDGN201 TARGTEPO secreting EPO

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-01-01
• Completion: 2016-06-01
• First posted: 2015-03-04
• Last updated: 2018-10-19
• Results posted: 2018-10-19

Locations

2 sites across 1 country: Israel