Prospective, Open-label, Multicentric, Phase IV study to substantiate the Safety and Efficacy of Renadyl in the patients of stage III and IV of Chronic Kidney Disease (CKD).

Centaur Pharmaceuticals Pvt Ltd0 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

试验速览

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•1) Patients of stage III and IV chronic kidney disease (GFR from 15-59mL/min per 1.73 m2)
•2) Willing to sign on informed consent form
•3) Patients who can adhere to the Protocol

•1) Patients known, or thought to be hypersensitivity to study product
•2) Patients on dialysis or have undergone dialysis in the past
•3) Pregnant or Lactating Women
•4) HIV/AIDs and Liver disease patients
•5) Antibiotic treatment at the time of screening or within 30 days before screening
•6) Immunosuppressive treatment at the time of screening or within 90 days before screening
•7) Patients suffering from Irritable Bowel Syndrome, Inflammatory Bowel Disease and patients who have undergone resection surgeries of the GI tract
•8) Patients with CKD due to obstructive uropathy and ADPKD
•9) Patients having severe cardiac arrhythmias and grade III & IV (NYHA classification) of CHF
•10) Patients with active dependency on drugs/alcohol for the last 12 months
•11) Patients having history of taking any probiotic for 3 months at the time of screening
•12) Patients who cannot adhere to the Protocol (Mentally Ill and Patients with Psychological problem)

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