SAVE-Care (SGLT2i As Novel Gout Care) Trial

SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors [SGLT2i] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate [SU] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein [hsCRP] and interleukin 6 [IL-6], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.

CT.gov Identifier
NCT06674109
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Massachusetts General Hospital
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Chronic Kidney Disease
Study Drug
Empagliflozin
Genes
N/A
Study Dates
May 2026 - Feb 2028
Sex
Female & Male
Age
18 - 80 Years
Inclusion and Exclusion Criteria
Inclusion Criteria:
  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • 1. Provision of signed and dated informed consent form.
  • 2. Fulfilling American College of Rheumatology [ACR]/European Alliance of Associations for Rheumatology [EULAR] gout criteria
  • 3. 1+ gout flares in last 12 months
  • 4. Serum urate level ≥ 6mg/dl
  • 5. Males and females; Age 18-80
  • 6. Willingness to adhere to the study intervention procedures.
Exclusion Criteria:
  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • 1. Estimated Glomerular Filtration Rate [eGFR] <20ml/min
  • 2. Colchicine or nonsteroidal anti-inflammatory drug [NSAID] prophylaxis
  • 3. active cardiovascular disease [CVD], type-1 diabetes
  • 4. pregnant and lactating women
  • 5. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. [History of ketoacidosis, end-stage or decompensated liver disease, active cancer]
  • 6. Use of anti-obesity drugs
  • 7. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics

Protocol Summary

SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors [SGLT2i] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate [SU] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein [hsCRP] and interleukin 6 [IL-6], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.

Study Locations

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