NCT06224790已完成4 期
Effectiveness & Safety of Perfenidone in Type 2 Diabetic Patients With Diabetic Neuropathy: A Randomized Controlled Trial
Sidrah Lodhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 15% improvement in eGFR
研究概览
简要总结
The purpose of this study is to determine the effectiveness & safety of pirfenidone in type 2 diabetic patients with diabetic nephropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic Nephropathy Stage 3 (eGFR 30-59 mL/min/1.73m2) Type 2 Diabetes HbA1c <7.5% Patient taking ACEi/ARB for at least 3 months BP <140/90
排除标准
- •History of photosensitivity rash History of decompensated liver or cardiac disease History of urinary tract infection Pregnancy or lactation History of nephrotoxic drugs or hakeem medication Polycystic kidney disease History of autoimmune disease History of hypersensitivity to study drugs
研究组 & 干预措施
Group B
Placebo Comparator
Placebo capsules - 2 X 8hrly for 3 months
干预措施: Placebo (Other)
Group A (Pirfenidone)
Experimental
Capsule Pirfenidone 200mg, 2 X 8hrly for 3 months
干预措施: Pirfenidone (Drug)
结局指标
主要结局
15% improvement in eGFR
时间窗: 6 months
eGFR of the patients shall be evaluated for at least 15% improvement
次要结局
- Safety - Adverse Effects of Drugs(6 months)
研究者
Sidrah Lodhi
Assistant Professor of Medicine
King Edward Medical University
研究点 (1)
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