Effectiveness of supplementation of Nefrosave® in Chronic Kidney Disease

Not Applicable

Conditions: Health Condition 1: N181- Chronic kidney disease, stage 1Health Condition 2: N182- Chronic kidney disease, stage 2 (mild)

Registration Number: CTRI/2020/04/024476

Lead Sponsor: Fourrts India Laboratories Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change from baseline to study end in estimated glomerular filtration rate using the MDRD calculation <br/ ><br>2. Mean change from baseline to study end in urinary albumin/creatinine ratio <br/ ><br>3. Mean change from baseline to study end in serum cystatin cTimepoint: Visit 1 (Day 1) <br/ ><br>Visit 2 (Day 30) <br/ ><br>Visit 3 (Day 90) <br/ ><br>Visit 4 (Day 180)

Secondary Outcome Measures

Name	Time	Method
Time to event: time until the occurrence of an event of interest i.e haemodialysis, requirement for renal transplant or enhancement of current management.Timepoint: Visit 1 (Day 1) <br/ ><br>Visit 2 (Day 30) <br/ ><br>Visit 3 (Day 90) <br/ ><br>Visit 4 (Day 180)