Assessment of Safety and Efficacy of SGLT2is Among LN Patients

October 27, 2023 updated by: Marwa Ahmed Mohamed Ahmed Waly, Ain Shams University

Assessment of Safety and Efficacy of Sodium Glucose Co-transporter 2 Inhibitors Among Lupus Nephritis Patients

The aim of this study is to assess the safety and efficacy of SGLT2is among LN patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

SLE is a chronic debilitating autoimmune disorder that involves multiple organ systems either simultaneously or sequentially with relapsing and remitting course. The word 'Lupus' is a Latin term which means wolf.

Lupus nephritis (LN) is one of the common complications in patients with SLE and influences overall outcome of these patients. About two-thirds of patients with SLE have renal disease at some stage which is a leading cause of mortality in these patients.

Manifestations of LN vary from asymptomatic urinary abnormalities to rapidly progressive crescentic glomerulonephritis to end-stage renal disease (ESRD).

Recently, metabolic modulation approach has become a hot spot in the management of SLE. Increased glucose metabolism in immune cells has been reported in patients with SLE.

Repurposing metformin, an old anti diabetic drug, has the potential to reduce the risk of lupus flare in randomized controlled trials. A recent crossover study implied that peroxisome proliferator-activated receptor-gamma agonists might decrease cardiovascular risk in patients with SLE.

Dapagliflozin, SGLT2i, is a new therapy for type 2 diabetes. The Dapagliflozin mode of action is to reduce glucose reabsorption in the epithelial cells of the proximal renal tubule of the kidney, which results in decreased blood glucose and glycated hemoglobin levels.

Strikingly, four cardiovascular outcome trials demonstrated that treatment with SGLT2is (empagliflozin, canagliflozin and dapagliflozin) in patients with type 2 diabetes had prominent effects on slowing the decline rate of eGFR and decreasing albuminuria, as well as a significant reduction in cardiovascular events.

Furthermore, the nephroprotective efficacy of SGLT2is was extended to non-diabetic CKD, such as IgA nephropathy.

The net gain of SGLT2 inhibition is to reduce renal workload and to modulate weight loss and blood pressure.

The paradigm for CKD and congestive heart failure management has been shifted accordingly

Interestingly, all researchers have reported that SGLT2is could block lipopolysaccharide-induced and NLRP3-mediated inflammatory responses and regulate macrophage polarization via interplay with mammalian target of rapamycin (mTOR) and AMP-activated protein kinase pathway thereby, SGLT2is might further contribute to reducing inflammation, modulating endothelial dysfunction and decelerating atherosclerosis which are all relevant to the pathophysiology of SLE.

Here, the investigators initiated this study aiming to assess the safety and efficacy of dapagliflozin among patients with LN.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Marwa Abdel Samie, Lecturer
  • Phone Number: 01278064363

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Ain shams university
        • Contact:
          • Howida Al Shennawi, Professor
          • Phone Number: 01223429592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged more than 18 year.
  • Patients with confirmed SLE according to EULAR/ACR classification criteria.
  • Patients with LN ( persistent proteinuria > 2 gm per day or greater than 3+ by dipstick, and/or cellular casts including red cell, hemoglobin, granular, tubular or mixed & "active urinary sediment" (>5 RBC/hpf, >5 WBC/hpf in the absence of infection, or cellular casts limited to RBC or WBC casts )
  • Patient with e GFR > 25 ml/min/1.73m2 by CKD-EPI equation.

Exclusion Criteria:

  • Patients with an allergy or intolerance to Dapagliflozin or any prior SGLT2i exposure within 1 month before screening.
  • Medical history of chronic disease (Severe respiratory distress, gastrointestinal tract lesions & chronic liver disease)
  • Patients with recurrent genitourinary infections.
  • Patient with proteinuria < 2gm.
  • Patient who show response to immune therapy in proteinuria reduction > 50%.
  • Patient with Lupus in induction phase.
  • Patient on steroids > 30 mg daily dose.
  • Patients with diabetes mellitus.
  • Patients with severe infection requiring antibiotics within 1 month before screening.
  • Patients with malignant diseases.
  • Pregnant or breast-feeding women.
  • Patients with eGFR < 25 ml/min/1.73m2 or undergoing dialysis therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug as Dapagliflozin 10 mg orally for 6 months is given
25 lupus nephritis patients will receive SGLT2is as dapagliflozin 10mg beside there usual treatment of lupus for 6 months
Drug: Dapagliflozin 10mg Tab orally once daily
Sodium glucose co-transporter 2 inhibitors
Other Names:
  • Empagliflozin 10 mg tab orally once daily
No Intervention: On there conventional lupus nephritis treatment
25 lupus nephritis patients didn't receive SGLT2i and continue on their conventional lupus nephritis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function Tests:
Time Frame: 6 months
  1. Measurement of serum urea level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
  2. Measurement of serum creatinine level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
  3. Measurement of serum uric acid level in mg/dl at 3 month's interval, that is, at 0, 3 and 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Howaida Al-Shennawi, Professor, Professor of internal medicine and Nephrology
  • Study Director: Cherry Kamel, Professor, Professor of internal medicine and Nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGLT2I among LN patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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