THE STUDY OF DESIDUSTAT EFFICACY VERSUS DARBEPOETIN ALFA FOR TREATMENT OF ANEMIA IN CHRONIC KIDNEY DISEASE PATIENTS ON HEMODIALYSIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin level :Change in Hb levels from baseline
研究概览
简要总结
· Patient undergoing maintenance hemodialysis in nephrology department will be screened on the basis of inclusion and exclusion criteria and will be included in the study.
· Informed consent will be obtained
· Patient fulfilling the inclusion criteria and willing to participate will be included in the study
· The study patients will be randomly assigned in 1:1 ratio to receive either the desidustat oral tablet or the darbepoetin alfa subcutaneous injection.
· A detailed history will be taken and basic laboratory test will be done such as cbc , renal function test , transferrin saturation , serum iron , lipid profile , CRP ,virals will be done .
· The treatment duration will be 16 weeks. Patients hemoglobin level will be checked every week during 1st month of study , followed by once in 15days for next 3 months
· To maintain adequate iron status, the iron supplementation (oral or parenteral) was allowed based on assessment of the iron profile (serum ferritin, serum iron, and TSAT)
· Rescue medication (e.g., ESA and red blood cell transfusion) will be reserved for the patients whose hemoglobin level dropped below 7 g/dL or decreased by ≥2 g/dL from the baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Ability to understand and given informed consent for participation 2)Male or female patients diagnosed with CKD Stage V 3)Aged ≥18 years at screening visit.
- •Patients on hemodialysis (≥2 times in a week) for at least 12 weeks prior to screening visit and had access consisting of an arteriovenous fistula, AV graft, or permanent catheter).
- •Patients with no planned change in dialysis modality and with no planned renal transplant during study period.
排除标准
- •Red blood cell transfusion within 8 weeks prior to participating in the study.
- •Had history of previous or concurrent cancer.
- •Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus (HIV) infection.
- •Active infection at initiation of study.
- •Had history of renal transplant.
结局指标
主要结局
Hemoglobin level :Change in Hb levels from baseline
时间窗: 16 week time period
次要结局
- 1) Hemoglobin Response :No. of subjects with Hb response(2)Hemoglobin target range :Time to achieve target range Hb level)
研究者
SOHIL SHARDA
Jawaharlal Nehru Medical College, belagum