Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00542568
Eligibility Criteria:
Inclusion Criteria:
1. Adult male or female subjects between 18 to 75 years of age at the time of screening visit.
2. Subject with Anemia of Chronic Renal Failure CKD stage 3-4. estimated GFR of 15-60 ml/min with Female: Hb \< 10 g%, Male: Hb \< 11 g%.
3. Chronic renal failure subjects who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than four (4) weeks.
4. Subjects who are clinically stable.
5. Adequate iron stores (transferrin saturation ≥ 20.0% and ferritin ≥100 ng/ml).
6. Subjects who receive anti-coagulation treatment may be enrolled provided anti-coagulation treatment can be discontinued two weeks prior to the harvesting visit. INR level must be within normal range (0.9 - 1.5).
Signed written informed consent to participate in the study by subject
Exclusion Criteria:
1. Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
2. Congestive heart failure (New York Heart Association functional class III or IV).
3. Grand mal seizures within 2 years of the screening visit.
4. Clinical evidence of severe hyperparathyroidism as defined by PTH levels of \> 10 times the upper normal limits.
5. Major surgery within 12 weeks of the screening visit.
6. Systemic hematologic diseases (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia).
7. Current systemic infection, active inflammatory disease, or malignancy under treatment.
8. Known positivity for HIV antibody.
9. Subjects known to have tested positive at any time in the past for antibodies to erythropoietic proteins.
10. Subject has history of malignancy within the past 2 years prior to the screening visit, with the exception of basal cell carcinoma.
11. 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).
12. 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).
13. Psychiatric, addictive, or any other disorder that compromises ability to give truly informed consent for participation in this study.
14. Female subjects of child-bearing potential and not having undergone permanent sterilization procedures.
15. Pregnant and lactating female subjects.
16. Chronic alcoholic or drug abuse subjects.
17. Steroid or other immunosuppressive treatment.
18. Subjects unwilling or unable to comply with the study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00542568
Study Brief:
Protocol Section:
NCT00542568