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A RANDOMISED CONTROL TRIAL ON ADDING DAPAGLIFLOZIN TO LUPUS NEPHRITIS TREATMENT

A COMPARISON BETWEEN STANDARD OF CARE TREATMENT AND DAPAGLIFLOZIN ADDED TO STANDARD OF CARE TREATMENT IN LUPUS NEPHRITIS PATIENTS

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049898
Enrollment
50
Registered
2023-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement

Interventions

Intervention1: DAPAGLIFLOZIN 10MG ONCE DAILY FOR 12 MONTHS: DAPGLIFLOZIN 10MG ONCE DAILY WILL BE GIVEN ALONG WITH STANDARD OF CARE TREATMENT Control Intervention1: STANDARD OF CARE TREATMENT: INDUCTIO

Sponsors

DR MANISH RATHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ALL NEWLY DIAGNOSED SYSTEMIC LUPUS ERYTHEMATOSUS WITH BIOPSY PROVEN LUPUS NEPHRITIS (CLASS III,IV,V,III+V,IV+V) ARE ELIGIBLE IF THEY ARE ABOVE 18 YEARS OF AGE

Exclusion criteria

Exclusion criteria: 1. PATIENTS HAVING PULMONARY ALVEOLAR HEMMORHAGE 2. PATIENTS WITH NEUROPSYCHIATRIC SLE 3. PATIENT WITH RAPIDLY PROGRESSIVE RENAL FAILURE 4. PATIENTS WHO ARE ON HEMODIALYSIS 5. PATIENTS WITHH eGFR LESS THAN 25 ml/min /1.73 m2 6. PATIENTS WITH BASELINE CREATININE MORE THAN 3 mg/dl 7. PATIENTS UNWILLING TO GIVE CONSENT

Design outcomes

Primary

MeasureTime frame
TREATMENT RESPONSE AFTER 6 MONTHS AS PER KDIGO GUIDELINES WITH SERUM CREATININE , 24HOUR URINE PROTEINTimepoint: TREATMENT RESPONSE AFTER 6 months of intervention

Secondary

MeasureTime frame
FREQUENCY OF URINARY TRACT INFECTIONS IN BOTH ARMSTimepoint: FOLLOWED UP EVERY MONTHLY FOR 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS;NUMBER OF LUPUS FLARES IN BOTH ARMSTimepoint: FOLLOWED UP EVERY MONTHLY TILL 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS;NUMBER OF SLE RELATED COMPLICATIONS AND DEATHS IN EACH ARMSTimepoint: FOLLOWED UP MONTHLY FOR 6 MONTHS AND 3 MONTHLY UNTIL 12 MONTHS

Countries

India

Contacts

Public ContactDr NIRANJAN A V

PGIMER CHANDIGARH

drmanishrathi2000@yahoo.co.in9216721287

Outcome results

None listed

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