A PROSPECTIVE, MULTI-CENTRIC, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECTIVENESS OF SUPPLEMENTATION OF N-ACETYLCYSTEINE& TAURINE IN PREVENTING PROGRESSION OF CHRONIC KIDNEY DISEASE

Introduction:

Chronic kidney disease is a slow and progressive loss of kidney function over a period of several years eventually leading to permanent kidney failure. CKD is known to be a risk factor for cardiovascular disease which inturn worsens CKD, making it a vicious cycle. The association of CKD with oxidative stress is a contributing factor to cardiovascular burden and is also proven to increase markers of inflammation like interlukins (IL’s), tumor necrosis factor (TNF-α) and C- Reactive Proteins (CRP) leading to progression of renal injury. The anti-oxidant effect of N-acetylcysteine (NAC) is seen to reduce the production of free radicals, inflammatory cytokines and serum creatinine. This study aims at evaluating the effect of Nefrosave® on the markers of CKD and compare the time of event of interest with placebo.

Methods:

Adult Patients between 18 - 65 years of age, of both gender with a diagnosis of chronic kidney disease (including type 2 diabetes mellitus associated chronic kidney disease) stage 1, stage 2 and stage 3 A (Stage 1 with normal or high GFR (GFR > 90 mL/min) Stage 2 Mild CKD (GFR = 60-89 mL/min Stage 3 Moderate CKD (GFR = 43-59 mL/min) as per National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) were included. Serum creatinine < 3.0 mg/dL, Subjects who are willing to give written informed consent were included in the study. Patients with Type 1 DM, severe CKD, history of MI, CABG/ PTCA/angioplasty/stent, Cerebrovascular event, Cardiac failure as per New York Heart Association Functional, allergies or intolerance to N- acetylcysteine or taurine, Untreated UTI/ medical condition impacting urine protein values, patients maintained on dialysis, BMI 30 kg/m2 or any other systemic disease/abnormal laboratory values that may interfere in the study were excluded. The objective of the study is to evaluate the delay in progression of chronic kidney disease by supplementing with Nefrosave® and compare with an identical placebo.

Results:

An 18.6% overall reduction in uACR was seen in Nefrosave® group compared to placebo with 34.09% reduction in micro albuminuria and 17.55% reduction in macro albuminuria Overall Cystatin C reduced by 21.89% in Nefrosave® group which is 36.9% more than Placebo group. 9.74% competitive reduction of serum Creatinine was shown in Nefrosave group compared to Placebo. A competitive reduction was also noted by 27.43% in CKD 1 & 2, 64.8% in CKD 3 respectively. [Fig 1 and 2]

Conclusions:

The combination of N-Acetylcysteine & Taurine (Nefrosave® of Fourrts India Laboratories Pvt Ltd, Chennai) with low protein diet is an effective therapy to slow down the progression of CKD as it shows significant reduction in Micro albuminuria, Cystatin C and Serum Creatinine.

I have potential conflict of interest to disclose.
This study was funded by Nefrosave® of Fourrts India Laboratories Pvt Ltd, Chennai, India

I did not use generative AI and AI-assisted technologies in the writing process.