Assessment of Effectiveness of Empagliflozin in the Management of Anemia in Type 2 Diabetes Patients with Early Stage of Chronic Kidney Disease- A Prospective Randomised COntrol Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Serum erythropoietin, ferritin and transferrin saturation will be assessed at baseline and after 3months.
研究概览
简要总结
The inclusion of Empagliflozin could be a superior idea in treating patients with both diabetes and CKD in the early stages compared with other counterparts oral hypoglycemic agents like gliptins (DPP-4 inhibitors), owing to its potential ability to stimulate erythropoiesis and prevent the occurrence or progression of anaemia. The considerations that need to be considered while using Empagliflozin are genital infections and urinary tract infections. This has been a well-studied drug for many years and the results of various meta-analysis studies are a testament to the safety of this drug. The drug also prevents the progression of albuminuria and keeps serum creatinine levels in check and is also effective in treating diabetes in early-stage CKD patients. The multidimensional action of this drug in treating diabetes and its associated co-morbidity of anaemia in patients belonging to the described study population strongly indicates that the benefits of including this drug in their treatment could outweigh the risks associated with it. Instead of using antidiabetic drugs and oral iron supplements along with the therapy, using this could reduce the “pill burden†on the patient thus improving medication adherence. The potential of the drug to prevent renal damage and address other major complications associated with CKD as a package justifies why this study could be beneficial, which could give way to a more optimized therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Estimated glomerular filtration rate 45 to 90 ml per minute .
- •Diabetic patients HbA1C greater than 6.5 percent Patients with haemoglobin less than 13.0 g per dL in males.
- •Haemoglobin less than 12.0 g per dL in females.
排除标准
- •End Stage Renal Disease patients Stage 4 Patients with hereditary iron metabolism disorders.
- •Patients with Type 1 Diabetes mellitus.
- •Patients with pre-existing Urinary tract or Genital infections and patients who develop this complication during the study.
- •Patient with pyelonephritis.
- •Patients already taking diuretics.
- •Pregnant and Lactating women.
- •Treatment with any other investigational drug within the previous 30 days of inclusion in the study.
- •Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
- •Difficulty in Socio Culture Communication.
结局指标
主要结局
Serum erythropoietin, ferritin and transferrin saturation will be assessed at baseline and after 3months.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Dr Kumar J S
SRM Medical College Hospital and Research Centre
