A study to find out if Dapagliflozin can improve kidney function and immune status in patients with SLE with renal involvement.

A randomized controlled trial of Dapagliflozin added to standard of care in proliferative lupus nephritis: Assessment of renal and immunological outcomes - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096189

Enrollment

Registered

2025-10-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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 OD, oral for 6 months Control Intervention1: Placebo: 1 tablet OD, oral for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Patients of SLE greater than 18 years satisfying the ACR and EULAR 2019 criteria with biopsy-proven pro-liferative lupus nephritis (Class III or IV or III+V or IV+V)

Exclusion criteria

Exclusion criteria: 1)Patients who are pregnant or lactating or planning to get pregnant in the study period. 2)Acutely ill patients with infections or sepsis or dialysis or having a life-threatening manifestation that will confound the effect of the study medication. 3)Patients with poor renal functions (eGFR less than 25ml per min per 1.73m2) and or baseline serum creatinine of greater than 3mg/dL and or other standard contraindications to SGLT2 inhibition 4)Refractory lupus nephritis: defined as those patients who have failed to achieve renal response with two or more induction treatments.

Design outcomes

Primary

Measure	Time frame
Proportion of patients who achieve the KDIGO 2024-defined complete renal response at 6 months.Timepoint: Proportion of patients who achieve the KDIGO 2024-defined complete renal response at 6 months.	—

Secondary

Measure	Time frame
1.To compare the rates of partial renal response at the end of 6 months between the two groups 2.To assess the renal (complete and partial) response as per KDIGO 2024 definition at the end of 1 year in the study group. 3.To compare rates of flares in both groups as per SELENA-SLEDAI Flare Index at 1 year 4.To compare rates of adverse events in both groups defined according to CTCAE, 2017. 5.To determine the overall differences in peripheral blood immune cell populations in both groups before and at 6 months after Dapagliflozin Timepoint: 1. 6 months 2. 1 year 3. 1 year 4. 6 months 5. 6 months	—

Measure

Time frame

1.To compare the rates of partial renal response at the end of 6 months between the two groups 2.To assess the renal (complete and partial) response as per KDIGO 2024 definition at the end of 1 year in the study group. 3.To compare rates of flares in both groups as per SELENA-SLEDAI Flare Index at 1 year 4.To compare rates of adverse events in both groups defined according to CTCAE, 2017. 5.To determine the overall differences in peripheral blood immune cell populations in both groups before and at 6 months after Dapagliflozin Timepoint: 1. 6 months 2. 1 year 3. 1 year 4. 6 months 5. 6 months

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Countries

India

Contacts

Public ContactSriyanka Mohapatra

Jawaharlal Institute of Postgraduate Medical Education and Research

mollymthabah@jipmer.ac.in8903200854

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026