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CTRI Number  CTRI/2025/07/091914 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Probiotic 
Study Design  Single Arm Study 
Public Title of Study   Evaluating Renadyl s Safety and Efficacy in Chronic Kidney Disease Patients. 
Scientific Title of Study   Observational Post Marketing Surveillance Study To Substantiate the Safety And Efficacy of Renadyl in the Patients of Stage III And IV of Chronic Kidney Disease (CKD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mayuresh Kiran  
Designation  Vice President Medical Services, Pharmacovigilance and NPD 
Affiliation  Centaur Pharmaceuticals Pvt Ltd  
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, Maharashtra India.

Mumbai
MAHARASHTRA
400055
India 
Phone  02267609156  
Fax    
Email  drmayuresh@centaurlab.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Pramita Waghambare  
Designation  Executive Pharmacovigilance and Biomedical Reasearch  
Affiliation  Centaur Pharmaceuticals Pvt Ltd  
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, Maharashtra India.

Mumbai
MAHARASHTRA
400055
India 
Phone  02267609341  
Fax    
Email  pramita@centaurlab.com  
 
Details of Contact Person
Public Query  
Name  Ms Aakansha Singh  
Designation  Officer Medical Services 
Affiliation  Centaur Pharmaceuticals Pvt Ltd  
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, Maharashtra India.

Mumbai
MAHARASHTRA
400055
India 
Phone  02267609341  
Fax    
Email  med_user2@centaurlab.com   
 
Source of Monetary or Material Support  
Centaur Pharmaceuticals Pvt Ltd Centaur House, Shanti Nagar, near Grand Hyatt, Vakola, Santacruz East, Mumbai, Maharashtra 400055  
 
Primary Sponsor  
Name  Centaur Pharmaceuticals Pvt Ltd 
Address  Centaur Pharmaceuticals Pvt. Ltd., Centaur House, near Hotel Grand Hyatt, Vakola, Santacruz (E), Mumbai 400 055, Maharashtra India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mayuresh Kiran  Centaur Pharmaceutics Pvt Ltd  Centaur House, Near Grand Hyatt, Vakola ,Santacruz East, Mumbai 400 055, India Department - Biomedical Research and Pharmacovigilance ,1st floor B-wing
Mumbai
MAHARASHTRA 		 02267609156

drmayuresh@centaurlab.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethicare Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (2) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Renadyl   Renadyl, each capsule contains 45 Billion CFU of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27) and Bifidobacterium longum (KB31) - 1 capsule B.I.D. for 180 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.]Ages: 18-75 years
2.]Gender eligible for Study: both Males and Females
3.]Patients of stage III and IV chronic kidney disease (GFR from 15-59mL/min per 1.73 m2)
4.]Willing to sign on the informed consent form
5.]Patients who can adhere to the Protocol
 
 
ExclusionCriteria 
Details  1.]Patients known to be hypersensitive to the 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)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 

1. Reduction in Serum Creatinine Level
2. Reduction in Blood Urea Nitrogen (BUN) Level
3. Reduction in Serum Urea Level
4. Reduction in Serum Uric Acid Level  		 At day 1, day 90 and day 180  
 
Secondary Outcome  
Outcome  TimePoints 
1.Elevation in Creatinine Clearance
2. Elevation in estimated Glomerular Filtration Rate (eGFR)
3. Complete Blood Count (CBC)  		 At day 1, day 90 and day 180  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Renadyl [each capsule contains 45 Billion CFU of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27) and Bifidobacterium longum (KB31)] is a FSSAI approved nutraceutical product used as a supportive therapy for stage III and stage IV chronic kidney disease patients.

In Patients of chronic kidney disease the kidney function declines, nitrogenous wastes builds up in the blood and diffuses into the intestinal fluid by natural physiological process in colon via an extensive network of blood vessels. Probiotic microbes present in Renadyl enter the large intestine through ileo-caecal junction. Once they reach in the colon, the microbes target and metabolize the uremic nitrogenous wastes as nutrients for its growth, the microbes begin to multiply, and this in turn allows for even greater diffusion of nitrogenous wastes from the circulating blood stream into the bowel.

Several clinical trials of Renadyl in patients suffering from CKD of stage III and stage IV found that Renadyl is efficacious for reduction in BUN, Serum creatinine, C-reactive protein, Uric acid, Total Indoxyl glucoronide with increase in eGFR and the quality of life. It was also found to be with acceptable safety profile. Taking into account, the superiority in efficacy and safety along with patient compliance, we are proposing this phase IV clinical trial of Renadyl in India. The main rationale behind this clinical trial is to test the efficacy and safety of Renadyl in Indian patients and document the same thing.

 
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