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Effect of Two Different Levels of Blood Bicarbonate on Kidney Function in Adults with Chronic Kidney Disease

Effect of lower vs higher serum bicarbonate targets with oral bicarbonate therapy on kidney disease progression in chronic kidney disease: A randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095586
Enrollment
148
Registered
2025-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 2: N184- Chronic kidney disease, stage 4 (severe) Health Condition 3: N185- Chronic kidney disease, stage 5

Interventions

Intervention1: 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 wher

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults more than 18 years of age Participants with serum bicarbonate less than 18 millimol per litre, with or without oral bicarbonate supplementation OR patients with serum bicarbonate less than 20 millimol per litre and are on oral sodium bicarbonate at screening. CKD patients stage 3 to 5.

Exclusion criteria

Exclusion criteria: 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 m ). Pregnant and lactating women. Patients who refuse to provide written informed consent.

Design outcomes

Primary

MeasureTime frame
Change in estimated glomerular filtration rate between the groups.Timepoint: 12 months.

Secondary

MeasureTime frame
Changes in muscle mass and muscle strengthTimepoint: 1 year;Changes in blood pressure, volume overload and hyperkalemiaTimepoint: 1 year;Nutritional statusTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Indu Ramachandra Rao

Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal

indu.rao@manipal.edu9592896393

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026