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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT00399269
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18 to 70 yrs of age of either sex.
* CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.
* Patients who are willing to give the consent
* Patient with Anemia of Chronic Renal Failure with Hb \< 10.
Exclusion Criteria:
* Patients who are known hypersensitive to rHu-EPO.
* Patient's with history of anemia due to causes other than anemia of CRF.
* Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.
* Patient's with history of G.I. bleeding (Overt or Occult).
* Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.
* Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.
* Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.
* Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00399269
Study Brief:
Protocol Section:
NCT00399269