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CTRI Number  CTRI/2025/10/095586 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On: 09/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Two Different Levels of Blood Bicarbonate on Kidney Function in Adults with Chronic Kidney Disease 
Scientific Title of Study   Effect of lower vs higher serum bicarbonate targets with oral bicarbonate therapy on kidney disease progression in chronic kidney disease: A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shravana N C 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Room No. 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9449342562  
Fax    
Email  shravana1.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu Ramachandra Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Room No. 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India

Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Indu Ramachandra Rao 
Designation  Additional Professor 
Affiliation  Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal 
Address  Room No. 15, Department of Nephrology, Kasturba Hospital, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India


KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NA] 
 
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 
Shravana N C  Kasturba Medical College, Manipal  Room No. 15, Department of Nephrology,Sharda Pai OPD, Kasturba Hospital Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal,Udupi Karnataka, India, 576104
Udupi
KARNATAKA 		 9449342562

shravana1.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics 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), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Sodium bicarbonate  Sodamint 300 mg will be administered to the patients with a dose of 0.25 mEq per kg of their lean body weight per day for the lower bicarbonate target group where we except to maintain the serum bicarbonate levels within a range of 20 to 24 mmol/L(Frequency of administration is daily). The route of administration will be oral. The participants will be on the intervention from the day of the recruitment till the end of the study (for a period of 1 year).Dosings will be titrated at each follow ups depending upon their serum bicarbonate levels. 
Intervention  Oral Sodium bicarbonate   Sodamint 300 mg will be administered to the patients with a dose of 0.5 mEq per kg of their lean body weight per day in the higher bicarbonate target group where we expect to maintain the serum bicarbonate levels in a range of 24 to 28 mmol/L (Frequency of administration is daily). The route of administration will be oral. The participants will be on the intervention from the day of the recruitment till the end of the study (for a period of 1 year).Dosings will be titrated at each follow ups depending upon their serum bicarbonate levels. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adults more than 18 years of age
Serum bicarbonate level of less than 18 millimol per litre.
CKD patients stage 3 to 5. 
 
ExclusionCriteria 
Details  Patients who are on dialysis or with a history of transplantation.
History of advanced heart failure (NYHA Class III and IV) or significant left ventricular dysfunction (ejection fraction less than 40 percent)
Patients with structural and functional anomalies of the gastrointestinal tract, chronic liver disease, active malignancies, and chronic infections.
Uncontrolled hypertension more than 160/100 mmHg.
Morbid obesity (BMI more than or equal to 40 kg per m²).
Pregnant and lactating women.
Patients who refuse to provide written informed consent. 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in estimated glomerular filtration rate between the groups.  12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in muscle mass and muscle strength  1 year 
Changes in blood pressure, volume overload and hyperkalemia   1 year 
Nutritional status  1 year 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
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)   01/11/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  		 This randomized controlled trial will examine whether maintaining a higher serum bicarbonate target (24 to 28 millimol per litre) versus a lower target (20 to 24 millimol per litre) using oral sodium bicarbonate slows chronic kidney disease (CKD) progression. Adults more than or equal to 18 years with CKD stages 3 to 5 and serum bicarbonate less than 18 millimol per litre not on bicarbonate supplementation or less than 20 millimol per litre with or without bicarbonate supplementation will be randomized in a 1:1 ratio using opaque sealed envelopes for allocation concealment. The higher target group receives 0.5 mEq per kg of lean body weight per day, and the lower target group 0.25 mEq per kg of lean body weight per day, titrated to targets. The primary outcome is eGFR change over 12 months, and secondary outcomes include muscle mass, strength, nutrition, blood pressure, and hyperkalemia in 148 participants. 
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