NCT02117427

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (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.

Detailed 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

Conditions

• Chronic Kidney Disease
• End Stage Renal Disease

Interventions

Type	Name	Description
BIOLOGICAL	MDGN201 TARGTEPO	Erythropoietin secreted by TARGTEPO transduced with MDGN201

Timeline

• Start date: 2014-05-27
• Primary completion: 2016-06-30
• Completion: 2017-03-20
• First posted: 2014-04-21
• Last updated: 2018-10-30
• Results posted: 2018-10-30

Locations

5 sites across 1 country: Israel