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Safety and Efficacy of Sustained Erythropoietin Therapy

NCT00542568 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2014-04-17

No results posted yet for this study

Summary

The purposes of this study are to assess safety, efficacy, and subject satisfaction of EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic EPO in the body, using a small tissue explant from the patient's own skin) treatment in Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.

Conditions

Interventions

BIOLOGICAL

EPODURE (dermal Biopump for erythropoietin)

Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump

Sponsors & Collaborators

  • Medgenics Medical Israel Ltd.

    lead INDUSTRY

Principal Investigators

  • Prof. Eithan Galun, M.D · Hadassah Medical Organization

  • Doron Schwartz, MD · Tel-Aviv Sourasky Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-07-31
Completion
2013-01-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542568 on ClinicalTrials.gov