A study on effect of metabolic acidosis correction on progression of CKD

Effect of correction of metabolic acidosis on CKD progression – A randomised controlled trial - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076264

Enrollment

126

Registered

2024-11-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: N189- Chronic kidney disease, unspecified

Interventions

Intervention1: Standard of care for CKD and Sodium Bicarbonate tablets: The intervention arm will receive the standard of care for CKD and generic sodium Bicarbonate 500mg tablet containing 6mEq of bi

Eligibility

Inclusion criteria

Inclusion criteria: 1.Chronic kidney disease stage 3 and 4. 2.Venous bicarbonate levels 18-22 mEq/L documented on 2 occasions 1 month apart 3.should not have received bicarbonate supplementation for a period of 4 weeks prior to recruitment 4.documented stable eGFR, less than 5 percentage change in the preceding 3 months

Exclusion criteria

Exclusion criteria: 1.Symptomatic Hypocalcemia 2.Patients being considered for elective renal replacement in the subsequent six months 3.Patients with any significant comorbidities limiting life expectancy 4.Nephrotic range proteinuria 5.Decompensated heart failure with New York heart association (NYHA) class 3 or 4 symptoms 5.Decompensated chronic liver disease 6.Pregnancy 7.Persistent volume overload despite optimal diuretic therapy 8.Kidney transplant 9.Use of immunosuppression 10.A recent history of acute kidney injury (according to the KDIGO criteria) in the preceding three months, prior to recruitment 11.Respiratory disorders associated with hypercapnia 12.serum potassium less than 3 or more than 5.5 milliequivalent per litre. 13.serum bicarbonate less than 18 meq per litre 14.Uncontrolled hypertension as defined by BP more than SBP 160 and DBP 90 on maximal dosage of three antihypertensives and one diuretic

Design outcomes

Primary

Measure	Time frame
1.To assess the effect of metabolic acidosis correction on eGFR in patients with CKD stage 3 and 4 2.To assess the effect of Metabolic acidosis correction on urine albumin creatinine ratio in patients with CKD stage 3 & 4 Timepoint: 0 and 6 months	—

Secondary

Measure	Time frame
To assess the effect of MA correction on dietary acid load(Net endogenous acid production, potential renal acid load and urine net acid excretion )in patients with CKD stage 3 & 4 Timepoint: 0 and 6 months	—

Countries

India

Contacts

Public ContactDr Swathy Raju

Jawaharlal institute of postgraduate medical education and research

swathiraju7777@gmail.com9447753585

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026