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A randomised controlled trial on adding Dapagliflozin to lupus nephritis treatment

A comparison between standard of care treatment and Dapagliflozin added to standard of care treatment in maintenance phase of lupus nephritis patients a randomised controlled trial pilot study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080581
Enrollment
50
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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: Dapagliflozin 10mg once a daily will be given along with Standard Of Care treatment for 12 months Control Intervention1: Standard Of Care Treatment: Maintenance therapy

Sponsors

DR MANISH RATHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All newly diagnosed Lupus Nephritis with biopsy proven(Classes - III, IV, V, III +V, IV+V) are eligible if they are above 18 year of age

Exclusion criteria

Exclusion criteria: 1.Patient having pulmonary alveolar haemorrhage 2.Patient with neuropsychiatric SLE 3.Patient with rapidly progressive renal failure 4.Patient who are on hemodialysis 5.Patient with eGFR less than 25ml per min per 1.73m2 6.Patient with baseline creatinine more than 3mg per dl 7.Patient unwilling to give consent

Design outcomes

Primary

MeasureTime frame
Treatment Response as per KDIGO guidelines, Serum Creatinine , 24hr urine proteinTimepoint: 6 months

Secondary

MeasureTime frame
Frequency of urinary tract infection in both Arms,Number of Lupus flare in both Arm, Number of SLE related complications & deaths in each Arms.Timepoint: Followed up after every monthly for 6 months & 3 monthly until 12 months.

Countries

India

Contacts

Public ContactDR YOGESH E KHANDAGALE

PGIMER

drmanishrathi@gmail.com9216721287

Outcome results

None listed

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