TARGTEPO Treatment for Anemia in PD US Trial

Anemia of End Stage Renal Disease Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia
• Anemia of End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT02468414
• Study type: Interventional
• Source: Cerecor Inc
• Status: Terminated
• Phase: Phase 2
• Start date: June 2015
• Completion date: September 2016