Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Medgenics Medical Israel Ltd. |
---|---|
Information provided by: | Medgenics Medical Israel Ltd. |
ClinicalTrials.gov Identifier: | NCT00542568 |
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.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Biological: EPODURE (dermal Biopump for erythropoietin) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of Sustained Erythropoietin Therapy of Anemia in Chronic Kidney Disease Patients Using EPODURE Biopump |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Cohort 1 (Low Dose group) 18-25 IU/kg/day
|
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
|
2: Experimental
Cohort 2 (Intermediate Dose group): 35-45 IU/kg/day
|
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
|
3: Experimental
Cohort 3 (High Dose group): 55-65 IU/kg/day
|
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
|
Anemia, is a common complication of chronic kidney disease (CKD) resulting from insufficient production of the hormone erythropoietin by the damaged kidney leading to a decrease in red blood cells production by the bone marrow.
Replacement therapy with recombinant human erythropoietin can effectively correct anemia in patients. However, despite the availability of recombinant human erythropoietin for more than a decade for use in CKD patients, two thirds of patients initiating dialysis have a hematocrit less than 30%, and three fourths have a hemoglobin (Hb) less than 11 g/dL the level recommended by the National Kidney Foundation Kidney Disease Outcome Quality Initiative. Treatment with recombinant human erythropoietin typically involves subcutaneous (SC) administration at regular intervals followed by frequent laboratory tests to monitor hemoglobin concentration. There is a need to provide an significantly improved care in this area using a sustained therapy approach.
EPODURE, is 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. The EPODURE biopump is harvested directly from the patient's dermis under local anesthetic. EPODURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral EPO vectors (HDAd-EPO), expresses and secretes EPO. The EPODURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of EPO.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Signed written informed consent to participate in the study by subject
Exclusion Criteria:
Contact: Ehud Shoshani, MD | 972-54-227-0908 | ehud@medgenics.com |
Israel | |
Hadassah Medical Organization | Recruiting |
Jerusalem, Israel | |
Contact: Arik Tzukert, DMD 972-2-677-6095 arik@hadassah.org.il | |
Contact: Hadas , Lemberg, PhD 972-2-677-7572 lhadas@hadassah.org.il | |
Principal Investigator: Prof. Eithan Galun, M.D | |
Sub-Investigator: Dr Michal Elhalel, M.D |
Principal Investigator: | Prof. Eithan Galun, M.D | Hadassah Medical Center |
Responsible Party: | ( Medgenics Medical Israel Ltd ) |
Study ID Numbers: | MG-001-02 |
Study First Received: | October 10, 2007 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00542568 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Epoetin Alfa Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |