NCT02468414

TARGTEPO Treatment for Anemia in PD US Trial

Safety & Efficacy of Prolonged Physiologic EPO Level Treatment of Anemia in ESRD Patients Undergoing Peritoneal Dialysis Using MDGN201 TARGTEPO

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (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 be administered with a targeted dose of 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 (18-25 IU/Kg/day)
BIOLOGICAL	MDGN201 TARGTEPO	MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2016-09-01
• First posted: 2015-06-10
• Last updated: 2022-03-28
• Results posted: 2017-07-13

Locations

1 site across 1 country: United States