SGLT2 Inhibitor in Lupus Nephritis Patients With Chronic Kidney Disease

NCT06155604 | Recruiting Phase 2 FDA Drug

• 1 other identifier: LN-SGLT2i
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Lupus nephritis (LN) is a common manifestation in patients with systemic lupus erythematosus (SLE), and is an important cause of acute kidney injury and chronic kidney disease (CKD). Although the standard-of-care treatments for active severe LN are effective, a substantial proportion of LN patients still develop CKD and eventually end-stage kidney disease (ESKD). Cardiovascular complications are common and is a leading cause of death in SLE and LN patients. It is well recognized that LN patients had multiple risk factors for cardiovascular complications such as diabetes mellitus (DM), dyslipidaemia and vascular inflammation. Sodium-glucose co-transporter 2 (SGLT2) inhibitor are initially developed as an oral anti-diabetic agent and has shown to be effective in glycaemic control, has benefits in lipid metabolism, cardiovascular and renal outcomes, and also well tolerated by patients. Various trials have also demonstrated the benefits of SGLT2 inhibitor in the reduction of CKD, ESKD, and renal or cardiovascular death. However, the effect of SGLT2 inhibitor in LN remains unclear. The purpose of this study is to investigate the effect of SGLT2 on renal outcomes in LN patients with CKD, as well as the side effects, metabolic profiles, immunological functions and disease stability.

Conditions

Lupus Nephritis; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• eGFR reduction

  Incidence of eGFR reduction by 30% or more at 24 months

  24 months

Secondary Outcomes (18)

• eGFR

  24 months

• Urine protein-to-creatinine (UPC) ratio

  24 months

• End-stage kidney disease (ESKD)

  24 months

• Fasting glucose

  24 months

• Hba1c

  24 months

Study Arms (2)

Treatment group

EXPERIMENTAL

standard maintenance therapy plus dapagliflozin 10 mg daily

Drug: Dapagliflozin 10mg Tab; Drug: Standard maintenance therapy

Control group

OTHER

standard maintenance therapy only

Drug: Standard maintenance therapy

Interventions

Dapagliflozin 10mg Tab DRUG

Dapagliflozin 10mg daily

Also known as: Farxiga, Forxiga

Treatment group

Standard maintenance therapy DRUG

Prednisolone 5-7.5 mg daily alone or in combination with Mycophenolate mofetil (\<=1.5 g/D) or Azathioprine (\<=150 mg/D)

Also known as: Cellcept, Imuran

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy-proven Class III or IV or V LN according to the ISN/RPS 2003 classification
• Patients with CKD (eGFR 15-60mL/min)
• Patients in quiescent disease (defined as SLEDAI score \<4 with no points in the renal domain)
• Patients on a stable dose of prednisolone (PRED 5-7.5 mg/D) alone or in combination with MMF (\<=1.5 g/D) or AZA (\<=150 mg/D) in the past 3 months

You may not qualify if:

• Patients with biopsy-proven glomerulonephritis other than LN or hereditary kidney diseases
• Patients with type 1 diabetes mellitus (DM)
• Patients with stage 5 CKD or ESKD on renal replacement therapy
• Patients with frequent urinary tract infections
• Patients with history of ketoacidosis

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Desai SB, Ahdoot R, Malik F, Obert M, Hanna R. New guidelines and therapeutic updates for the management of lupus nephritis. Curr Opin Nephrol Hypertens. 2024 May 1;33(3):344-353. doi: 10.1097/MNH.0000000000000969. Epub 2024 Feb 9.

  PMID: 38334499 DERIVED

MeSH Terms

Conditions

Lupus Nephritis; Renal Insufficiency, Chronic

Interventions

dapagliflozin; Mycophenolic Acid; Azathioprine

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Desmond Yap, MD (HK)

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desmond Yap, MD (HK)

CONTACT

85222554385; desmondy@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 4, 2023
• Study Start: January 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)