CTRI/2010/091/000064已完成3 期
Prospective, Multicentric, Open-label, Study to determine the Safety and Efficacy of ReliPoietin when given intravenously to Patients of CKD (Chronic Kidney Disease) with Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with Hb levels between 7 & 10g/dL (both inclusive).
- •2. Patients with chronic kidney disease
- •3. Patients with a therapeutic indication for treatment of anemia, after correction of
- •anemia secondary to iron, folate or B12 deficiency (Transferrin saturation > 20%,
- •Serum Ferritin > 100ng/ml)
- •4. Women of child bearing potential having a negative pregnancy test and taking
- •adequate birth control measures/documented to be postmenopausal
- •5. Able to comprehend and willing to give informed consent for the study and willing
- •to come for follow up visit as per protocol requirement. If the subject is illiterate,
- •then the consent will be taken in the presence of impartial witness.
排除标准
- •1. Patients with uncontrolled hypertension >=180/100 at screening
- •2. Patients with h/o blood clotting abnormalities
- •3. Patients with micro or macrocytosis (mean corpuscular volume 72 or 110 μm3)
- •4. Treatment for any infection with drugs known to affect erythropoiesis, including
- •androgens and angiotensin-converting enzyme (ACE) inhibitors.
- •5. Patients with known history of allergy to mammalian cell derived products
- •6. Patients with known history of allergy to human serum albumin
- •7. Inclusion to any other clinical trial within previous 28 days
- •8. Patients who are known hypersensitive to rHu-EPO
- •9. Patients with history of anemia due to causes other than anemia of CKD,
- •abnormal parathyroid hormone levels
- •10. Patients with history of Active infections, Hemoglobinopathies, Neoplastic
- •11. Patients with HIV infection
- •12. Patients with Known history of G.I. bleeding
- •13. Patients with history of serious or unstable medical or psychological conditions
- •that could compromise the patients safety or successful trial participation
- •14. Patients with abnormal liver function tests (SGOT2.5 X ULN, SGPT 2.5 X ULN,
- •Bilirubin 2.5 X ULN, Alkaline Phosphatase 2.5 X ULN). However, patients with
- •HBsAg and HCV positive can be included provided their transaminases are
- •15. Pregnant and lactating female patients
- •16. Patients unwilling or unable to comply with the study procedures.
- •17. History of Chronic alcoholic or drug abuse patients
- •18. Patients with other systemic disorders who are not suitable for enrolling into the
- •study on the discretion of the investigator.
研究者
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