| Eligibility |
Inclusion Criteria:
1. Adult male or female subjects between 18 to 80 years of age at the time of screening
visit.
2. Subject diagnosed with anemia due to Chronic Kidney Disease (CKD) Stage 5 on
peritoneal dialysis treatment for at least 6 months. Average Hgb during last month
between 9 to 12g/dL. Stable dose of ESAs over the past month prior to enrollment.
3. Hypertensive subjects are stable on anti HTN treatment for the past one month prior to
enrollment and has Systolic blood pressure (BP) below 150 and Diastolic BP below 90
upon enrollment.
4. Kt/V > 1.
5. INR = 1.2.
6. Serum albumin > 3.2.
7. Subjects with adequate iron stores (transferrin saturation > 20.0% and/or ferritin
>100 ng/ml).
8. Capable of providing 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 (e.g. warfarin).
3. Subjects who receive acetylsalicylic acid (ASA) 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 Harvest or Implantation Procedure.
4. Congestive heart failure (New York Heart Association functional class III or IV).
5. Grand mal seizures within 2 years of the Screening Visit.
6. Clinical evidence of severe hyperparathyroidism as defined by parathyroid hormone
(PTH) levels of > 10 times the upper normal limits.
7. Major surgery within 12 weeks of the Screening Visit.
8. Systemic hematologic diseases (e.g., sickle cell anemia, thalassemia (excluding
thalassemia minor), myelodysplastic syndromes, hematologic malignancy, myeloma,
hemolytic anemia).
9. Current systemic infection, active inflammatory disease, or malignancy under active
treatment.
10. Subjects known to have tested positive at any time in the past for antibodies to
erythropoietic proteins.
11. Subject has history of malignancy within the past 2 years prior to the Screening
Visit, with the exception of basal cell carcinoma.
12. Subjects with other concurrent severe and/or uncontrolled medical condition that could
compromise participation in the study (i.e. active infection, uncontrolled diabetes,
uncontrolled hypertension, congestive heart failure, unstable angina, ventricular
arrhythmias, active ischemic heart disease, myocardial infarction within six months,
uncompensated cirrhosis, active upper gastrointestinal (GI) tract ulceration).
13. Subject is currently enrolled in, or has not yet completed a period of at least 30
days or five half-lives of the investigational drug whichever is longer, since ending
other investigational device or drug trial(s) prior to Screening Phase.
14. Psychiatric, addictive, or any other disorder that compromises ability to provide
informed consent for participation in this study.
15. Female subjects of child-bearing potential and males that do not agree to use
acceptable methods of contraception during the study.
16. Pregnant or lactating female subjects.
17. Chronic alcoholic or drug abuse subjects.
18. Steroid or other immunosuppressive treatment (other than topical or inhaled steroids).
19. Subjects unwilling or unable to comply with the study procedures.
20. EPO-naïve subjects.
21. Known sensitivity to gentamicin and amphotericin.
22. History of chronic or active hepatitis B and/or C infection or positive serology at
screening, and known positive Human Immunodeficiency Virus (HIV) or positive serology
at screening.
23. Subject had a blood transfusion within 84 days prior to Screening Visit.
24. Subject has a date for renal transplantation.
25. Refer to the United States Product Insert (USPI) - Depo-Medrol (DM) -
Methylprednisolone Acetate - Injectable (Appendix A) for any concomitant drug taken by
the patient, which its interactions with DM will warrant exclusion from this protocol.
|
