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TARGTEPO Treatment for Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD)

Chronic Kidney Disease Clinical Trial

Official title:
Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease (CKD) Patients and End-Stage Renal Disease (ESRD) Dialysis Patients Using MDGN201 TARGTEPO

Clinical Trial Summary

The objectives of this study are to assess safety and to evaluate the biologic activity of TARGTEPO treatment.

Clinical Trial Description

This is a Phase I-II, open-label study. Each patient will receive targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to 3 cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day), Group C (55-65 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02117427
Study type Interventional
Source Aevi Genomic Medicine
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 27, 2014
Completion date March 20, 2017
View Details
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