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Which medicine works better to remove excess body fluid Dapagliflozin or Metolazone in kidney disease (with or without heart problem)

A Randomized Trial to Evaluate the Efficacy of Dapagliflozin versus Metolazone in Fluid Overload in Chronic Kidney Disease with or without Heart Failure - DAPACKD

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110789
Enrollment
50
Registered
2026-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N181- Chronic kidney disease, stage 1 Health Condition 2: N182- Chronic kidney disease, stage 2 (mild) Health Condition 3: N183- Chronic kidney disease, stage 3 (moderate) Health Condition 4: N184- Chronic kidney disease, stage 4 (severe)

Interventions

Intervention1: Oral Dapagliflozin 10 mg daily and metalozone 5 mg intermittently on day 1 and 3 and 5 to CKD patients with acute fluid overload not requiring dialysis: Oral dapagliflozin 10 mg once da

Sponsors

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH INSTITUTE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: AGE MORE THAN 18 YEARS CKD STAGE 2 TO 4 with eGFR 20 TO 75ml/min clinical evidence of fluid overload haemodynamically stable patients with mean arterial pressure of more than 60

Exclusion criteria

Exclusion criteria: End stage renal disease with egfr less than 20 Polycystic kidney disease Absolute indication for dialysis Kidney transplant patients Immune mediated glomerulopathies

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Percentage change in body weight from baseline in patients with CKD stage 2-4 presenting with acute fluid overload after one weekTimepoint: Primary Outcome: Percentage change in body weight after one week from baseline in patients with CKD stage 2-4 presenting with acute fluid overload

Secondary

MeasureTime frame
Clinical decongestion score at Day 7 composite of edema and dyspnea oxygen requirement and JVP Change in NT-proBNP from baseline to Day 7 Cumulative urine output during first 72 hours Bioimpedance parameters measurement total body water, extracellular water at Day 7 Length of hospital stay Cumulative loop diuretic dose requirementTimepoint: Clinical decongestion score at Day 7 Change in NT-proBNP from baseline to Day 7 Cumulative urine output during first 72 hours Bioimpedance parameters (total body water, extracellular water, ECW/TBW ratio) at Day 7 Proportion achieving clinical euvolemia by Day 7

Countries

India

Contacts

Public ContactDr Neeraj Singla

PGIMER CHANDIGARH

neerajsingladr@gmail.com9646121641

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026