1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  Data shall be made available with ethical committee


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NA

The purpose of this surveillance is to evaluate the safety and efficacy of Enzobiotics in combination Finerenone used in pre dialysis kidney disease patients and management of CKD progression.

Synbiotic and Proteolytic Enzymes given as food supplement are safe and have been used widely across the globe for year’s together (India, USA, Europe and other countries).  An Indian study on CKD 5D patients (patients on dialysis has shown) beneficial effect on serum creatinine level, BUN (blood urea nitrogen) and increase in serum protein level and improvement in quality of life. Since CKD patients are either malnourished or are at risk of developing malnutrition and cardiovascular disease, this food supplement is being given to CKD patients to prevent formation of harmful metabolites generated by undigested protein peptides and increase better utilization of protein in the body consequently preventing malnutrition and risk of cardiovascular disease which is an important cause of mortality in CKD patients. The Combination – Enzobiotics is clinical proven and has provides significant benefits in controlling Protein Bound Uremic Toxins PCS and IS which is responsible for the progression of CKD to CVD and also improves the QoL in CKD by reducing Uremic toxins and thus may postpone Dialysis.

Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist (MRA) that has emerged as an important therapeutic option for patients with chronic kidney disease (CKD) associated with type 2 diabetes mellitus (T2DM). Overactivation of the mineralocorticoid receptor contributes to inflammation and fibrosis in both the kidneys and cardiovascular system, accelerating disease progression. Finerenone exerts anti-inflammatory and antifibrotic effects by antagonizing this receptor, thereby reducing renal and cardiovascular complications. Clinical trials such as FIDELIO-DKD and FIGARO-DKD have demonstrated that finerenone significantly reduces the risk of kidney disease progression and cardiovascular events in patients with CKD and T2DM, with a more favorable safety profile compared to traditional steroidal MRAs. This study investigates whether the combination of Enzobiotics and Finerenone, a selective nonsteroidal mineralocorticoid receptor antagonist, offers additive or synergistic benefits in slowing CKD progression.

210 patients will take part in this study. You will be participating in the study approximately 180 days. Follow-up shall be done done for a period of 6 months post completion of the study.

First group of Subjects will be instructed to take the Enzobiotics twice daily 5 minutes before major food, second group of people will be instructed to take Finerenone (once daily) and third group of subjects shall take Enzobiotics (twice daily 5 minutes before major food) along with Finerenone (once daily anytime).

The patient response to Enzobiotics , Finerenone , and combinational regimen with Enzobiotics and Finerenone’s effect will be measured by laboratory investigation of all the efficacy parameter which will be conducted at all the visits of the study.