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CTRI Number  CTRI/2022/02/039964 [Registered on: 02/02/2022] Trial Registered Prospectively
Last Modified On: 25/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   SODIUM BICARBONATE AND CHRONIC KIDNEY DISEASE PROGRESSION 
Scientific Title of Study   A SINGLE-CENTER,PROSPECTIVE , RANDOMIZED, PARALLEL GROUP STUDY ON ROLE OF SODIUM BICARBONATE THERAPY IN RETARDING CHRONIC KIDNEY DISEASE PROGRESSION 
Trial Acronym  SOBIRC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARPITA RAY CHOUDHURY 
Designation  PROFESSOR OF NEPHROLOGY 
Affiliation  IPGME&R KOLKATA 
Address  INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH 244 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA

Kolkata
WEST BENGAL
700020
India 
Phone  9433254601  
Fax    
Email  lahiri.arpi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ARPITA RAY CHOUDHURY 
Designation  PROFESSOR OF NEPHROLOGY 
Affiliation  IPGME&R KOLKATA 
Address  INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH 244 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA

Kolkata
WEST BENGAL
700020
India 
Phone  9433254601  
Fax    
Email  lahiri.arpi@gmail.com  
 
Details of Contact Person
Public Query  
Name  RAJARSHI DATTA 
Designation  RESIDENT NEPHROLOGY 
Affiliation  IPGME&R KOLKATA 
Address  CD 6 SECTOR 1 SALT LAKE KOLKATA WEST BENGAL

Kolkata
WEST BENGAL
700064
India 
Phone  9163788388  
Fax    
Email  rajdatta89@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA 
 
Primary Sponsor  
Name  INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH KOLKATA 
Address  244 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA 700020 
Type of Sponsor  Research institution and hospital 
 
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 
PROF ARPITA RAY CHOUDHURY  INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RESEARCH  244 ACHARYA JAGADISH CHANDRA BOSE ROAD KOLKATA 700020
Kolkata
WEST BENGAL 		 9433254601

lahiri.arpi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R RESEARCH OVERSIGHT COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SODIUM BICARBONATE AND STANDARD OF CARE  SODIUM BICARBONATE 500MG BD/TDS FOR 12 MONTHS 
Comparator Agent  STANDARD OF CARE  STANDARD OF CARE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  CKD STAGE 3 AND 4
SERUM BICARBONATE LESS THAN 22 MMOL/L
STABLE CLINICAL CONDITION AS ASSESSED BY TREATING PHYSICIAN 
 
ExclusionCriteria 
Details  MALIGNANCY
MORBID OBESITY
COGNITIVE IMPAIRMENT
SEPSIS
POORLY CONTROLLED BLOOD PRESSURE
OVERT CONGESTIVE HEART FAILURE
AUTOIMMUNE DISEASE
LIMB AMPUTATION
POLYCYSTIC KIDNEY DISEASE 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
PROPORTION OF PATIENTS HAVING EGFR DECLINE MORE THAN 5 ML/MIN OR END STAGE KIDNEY DISEASE  12 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
CHANGES IN NUTRITIONAL STATUS
PROPORTION OF PATIENTS WITH ADVERSE EVENTS 		 12MONTHS 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   07/02/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [lahiri.arpi@gmail.com].

  6. For how long will this data be available start date provided 22-01-2024 and end date provided 22-01-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a single centre , prospective, randomized, parallel group study assessing the efficacy and safety of oral sodium bicarbonate therapy in addition to standard of care compared to standard of care alone in retarding progression of chronic kidney disease stages 3 and 4 with primary outcome of proportion of patients having egfr decline more than 5ml/min or reaching end stage kidney disease and secondary outcomes of changes in nutritional status and adverse events 
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