Phase IV clinical trial of Renadyl in the patients of stage III and IV Chronic Kidney Disease (CKD).

Phase 4

Not yet recruiting

• Conditions: Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)Health Condition 2: N184- Chronic kidney disease, stage 4 (severe)

• Registration Number: CTRI/2020/03/024198
• Lead Sponsor: Centaur Pharmaceuticals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Parameters: <br/ ><br>1. Reduction in Serum Creatinine Level <br/ ><br>2. Reduction in Blood Urea Nitrogen (BUN) Level <br/ ><br>3. Reduction in Serum Urea Level <br/ ><br>4. Reduction in Serum Uric Acid LevelTimepoint: At day 1, day 90 and day 180

Secondary Outcome Measures

Name	Time	Method
Secondary Efficacy Parameters: <br/ ><br>1. Elevation in Creatinine Clearance <br/ ><br>2. Elevation in estimated Glomerular Filtration Rate (eGFR) <br/ ><br>3. Complete Blood Count (CBC)Timepoint: At day 1, day 90 and day 180