A Randomized, Open Label, Three Arm, Comparative, Controlled, Single-center Study to Evaluate the Effect of Low Protein Diet Supplementation with Taurine and N-Acetylcysteine (Tab. Nefrosave) and N-Acetylcysteine and Pyridoxamine Dihydrochloride (Tab. Nefrosave Forte) in Preventing Progression of Chronic Renal Failure in Patients with Non-Diabetic Kidney Disease.

Dr Pratim Sengupta0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1)Ability to understand and provide informed consent for participation in the study
•2)Males or females >=18 or <=70 years of age
•3)Chronic renal failure patients with GFR more than 15 ml/min/1.73m2 and less than 60ml/min/1.73m2 receiving standard of care based on investigatorâ??s discretion
•4)Life expectancy greater than one year
•5)Non diabetic patients
•6)Well controlled blood pressure (MAP <125mm of Hg)

•1)Patient incapable of following study requirement to control diet
•2)Patient with ongoing acute inflammation or AKI
•3)Patients maintained on dialysis
•4)Patient anticipating for kidney transplant within next 6 months, or those who had a kidney transplant
•5)Proteinuria >10gm/day
•6)Hb <8g/dl or >16g/dl
•7)BMI <18 or >30 kg/m2
•8)Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from Day 1 until the month 6 visit
•9)Participation in other product clinical trial within 30 daysâ?? prior to this trial
•10)Any other systemic disease or any other abnormal laboratory values which as per investigator will interfere with patientâ??s participation in study

发起方

Dr Pratim Sengupta