SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts General Hospital

About this 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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form.

Fulfilling American College of Rheumatology [ACR]/European Alliance of Associations for Rheumatology [EULAR] gout criteria

1+ gout flares in last 12 months

Serum urate level ≥ 6mg/dl

Disqualifiers

Estimated Glomerular Filtration Rate [eGFR] <20ml/min

Colchicine or nonsteroidal anti-inflammatory drug [NSAID] prophylaxis

active cardiovascular disease [CVD], type-1 diabetes

pregnant and lactating women

Trial design

Treatments tested in this trial

  • Empagliflozin 10 mg
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators