Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant

Anemia Clinical Trial

Official title: Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in End Stage Renal Disease (ESRD) Dialysis Patients Using EPODURE Biopump

Status Terminated

Clinical Trial Summary

In this End Stage Renal Disease (ESRD) patients who need Erythropoietin (epo) hormone will get it by a small implant of skin using their own skin, the implant will be treated in the laboratory and programmed to secrete Epo. The implant secretes the patients own epo minimizing the need for injections for a period of up to 6 months.

Clinical Trial Description

This will be a Phase I-II, open-label, single-center, uncontrolled, tailored dose study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.

Subjects will undergo similar study procedures and evaluations; however each patient will receive his or her own individually targeted dose of EPO delivered via EPODURE Biopumps. The targeted dose may vary between 20IU/kg/d to 65IU/kg/d based on each patient's weight, the historical average EPO amount administered and historical Hb levels including at least the 3 months prior to inclusion in the study. The objective is maintaining Hb levels within the target range of 10-12 g/dl. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

• NCT number: NCT01555515
• Study type: Interventional
• Source: Medgenics Medical Israel Ltd.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Completion date: April 2014