Effectiveness and tolerability of N-acetylcysteine and taurine in patients of chronic kidney disease with type 2 diabetes mellitus and/or hypertension: A real-world, retrospective, comparative study from electronic medical records
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- 1. Change in urinary albumin to creatinine ratio (uACR) from baseline to 12±2 weeks of treatment
研究概览
简要总结
This real-world, retrospective, multicentric, comparative study will assess the effectiveness and tolerability of NAC (150 mg) and taurine (500 mg) on the management of microalbuminuria, creatinine levels, and eGFR in patients of CKD with T2DM and/or HTN (as diagnosed by the treating cardiologist) in India using data retrieved from electronic medical records (EMRs).
Aggregated and anonymized data will be retrieved for a period of at least 12+2 weeks after treatment initiation from approximately 450 EMRs (300 treated with NAC + taurine + standard of care; 150 treated with standard of care) of patients satisfying the study eligibility criteria.
Patient confidentiality will be maintained at all times, as the study will be performed using anonymized patient information only.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients more than and equal to 18 years of age
- •Diagnosis of stage 1, stage 2, or stage 3 chronic kidney disease (CKD) as per the National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI)
- •Diagnosis of type 2 diabetes mellitus (T2DM) and/or hypertension (HTN) by the treating cardiologist
- •Patients on standard of care with or without N-acetylcysteine (NAC; 150 mg) and taurine (500 mg), as prescribed by the treating cardiologist
- •Patients with available data on uACR, serum creatinine, and eGFR as part of routine clinical practice at least at baseline and after 12+2 weeks of treatment.
排除标准
- •Incomplete medical records with respect to the required study parameters.
结局指标
主要结局
1. Change in urinary albumin to creatinine ratio (uACR) from baseline to 12±2 weeks of treatment
时间窗: 1. Baseline to 12±2 weeks of treatment | 2. Baseline to 12±2 weeks of treatment
2. Change in serum creatinine levels from baseline to 12±2 weeks of treatment
时间窗: 1. Baseline to 12±2 weeks of treatment | 2. Baseline to 12±2 weeks of treatment
次要结局
- Change in eGFR from baseline to 12+2 weeks of treatment(Baseline, 12±2 weeks)
- Proportion of patients with adverse events (AEs) and serious AEs (SAEs)(Baseline to 12±2 weeks of treatment)
研究者
Dr Monjori Mitra
Medclin Research Pvt Ltd