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
- 试验地点
- 3
- 主要终点
- To achieve the rise in Hb in patients of Chronic Kidney Disease with anemia
研究概览
简要总结
This is a Prospective, Multicentric, Open-label, Study to determine the Safety and Efficacy of ReliPoietinTM when given intravenously to Patients of CKD (Chronic Kidney Disease) with Anemia. 75 subjects will be enrolled across multicenters in India. 10,000 IU of ReliPoietinTM will be administered once weekly for 8 weeks. Primary outcome will be the mean rise in Hb from baseline to EOS. Secondary outcome will be the safety of ReliPoietin during study period. Patients will be followed up to week 9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with Hb levels between 7 & 10g/dL (both inclusive).
- •Patients with chronic kidney disease
- •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)
- •Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures/documented to be postmenopausal
- •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
- •Patients with uncontrolled hypertension ≥180/100 at screening
- •Patients with h/o blood clotting abnormalities
- •Patients with micro or macrocytosis (mean corpuscular volume 72 or 110 μm3)
- •Treatment for any infection with drugs known to affect erythropoiesis, including androgens and angiotensin-converting enzyme (ACE) inhibitors.
- •Patients with known history of allergy to mammalian cell derived products
- •Patients with known history of allergy to human serum albumin
- •Patients who are known hypersensitive to rHu-EPO
- •Patients with history of anemia due to causes other than anemia of CKD, abnormal parathyroid hormone levels
- •Patients with history of Active infections, Hemoglobinopathies, Neoplastic diseases
- •Patients with HIV infection
- •Patients with Known history of G.I. bleeding
- •Patients with history of serious or unstable medical or psychological conditions that could compromise the patients safety or successful trial participation
- •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 normal
- •Pregnant and lactating female patients
- •Patients unwilling or unable to comply with the study procedures.
- •History of Chronic alcoholic or drug abuse patients
- •Patients with other systemic disorders who are not suitable for enrolling into the study on the discretion of the investigator.
结局指标
主要结局
To achieve the rise in Hb in patients of Chronic Kidney Disease with anemia
时间窗: 8 weeks
次要结局
- 1. To achieve improvement in hematocrit values(2. To study the safety of ReliPoietin)
研究者
研究点 (3)
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