Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant
Epodure Therapy of Anemia in End Stage Renal Disease on Dialysis With Epodure Skin Implant
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.
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.
Inclusion Criteria:1.

 1. Adult male or female subjects between 18 to 75 years of age at the time of screening
 visit.

 2. Subject diagnosed with Anemia due to Chronic Renal Failure CKD stage 5 on dialysis
 treatment for at least 3 months. Hb < 12g/dL on 2 consecutive measures

 3. Kt/V >1

 4. INR not higher than 1.2

 5. Subjects who are clinically stable.

 6. Serum albumin > 3.5

 7. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin >
 100 ng/ml).

 8. Signed written informed consent to participate in the study.

 Exclusion Criteria:

 1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic
 blood pressure > 180 mmHg during screening).

 2. Subjects who receive oral anti-coagulation treatment (warfarin)

 3. Subjects who receive Acetyl Salicylic Acid [(ASA), aspirin] above 325 mg/day or
 patients who receive ASA treatment between 100mg/d and 325 mg/d who cannot discontinue
 it for 1 week prior to each EPODURE procedure

 4. Patients currently receiving injections of long-acting ESA's (Aranesp, Mircera, etc.)

 5. Congestive heart failure (New York Heart Association functional class III or IV).

 6. Grand mal seizures within 2 years of the screening visit.

 7. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of > 10 times
 the upper normal limits.

 8. Major surgery within 12 weeks of the screening visit.

 9. Systemic hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndromes,
 hematologic malignancy, myeloma, hemolytic anemia).

 10. Current systemic infection, active inflammatory disease, or malignancy under
 treatment.

 11. Subjects known to have tested positive at any time in the past for antibodies to
 erythropoietic proteins.

 12. Subject has history of malignancy within the past 2 years prior to the screening
 visit, with the exception of basal cell carcinoma.

 13. Subjects with other concurrent severe and/or uncontrolled medical condition which
 could compromise participation in the study (i.e. active infection, uncontrolled
 diabetes, uncontrolled hypertension, congestive cardiac failure, unstable angina,
 ventricular arrhythmias, active ischemic heart disease, myocardial infarction within
 six months, uncompensated cirrhosis, active upper GI tract ulceration).

 14. Subject is currently enrolled in, or has not yet completed a period of at least 30
 days since ending other investigational device or drug trial(s).