A Prospective, Multi-Centric, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Effectiveness of Supplementation of Nefrosave® in Preventing Progression of Chronic Kidney Disease.

Fourrts India Laboratories Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年8月21日

试验速览

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•1. Adult Patients of both gender with a diagnosis of chronic kidney disease stage 1 and stage 2 (Stage 1 with normal or high GFR (GFR greater than 90 mL/min) Stage 2 Mild CKD (GFR is equal to 60-89 mL/min) as per National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI).
•2. Serum creatinine is less than 3.0 mg/dL
•3. Subjects who are willing to give written informed consent

•1. Type 1 diabetes mellitus
•2. Pregnant or lactating mothers
•3. Patients with severe chronic kidney disease
•4. Patients who have received a renal allograft
•5. Patients with a history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study start
•6. Cerebrovascular event within 3 months of study start
•7. Cardiac failure categorized as Class III or IV as per New York Heart Association Functional
•8. Known allergies or intolerance to N-acetylcysteine or taurine
•9. Untreated UTI or any medical condition that may impact urine protein values.
•10. Patients maintained on dialysis
•11. BMI <18 or > 30 kg/m2
•12. Any other systemic disease or any other abnormal laboratory values which as per investigator will interfere with patient’s participation in study
•13. Participating or planned participation in any other trial during the duration of the study.

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