NCT06674109 SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
| NCT ID | NCT06674109 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts General Hospital |
| Condition | Gout and Hyperuricemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2026-07-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Hyon K Choi, MD, DrPH
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06674109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Gout and Hyperuricemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06674109 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06674109 currently recruiting?
Yes, NCT06674109 is actively recruiting participants. Contact the research team at adfernandes@mgh.harvard.edu for enrollment information.
Where is the NCT06674109 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06674109 clinical trial?
NCT06674109 is sponsored by Massachusetts General Hospital. The principal investigator is Hyon K Choi, MD, DrPH at Massachusetts General Hospital. The trial plans to enroll 60 participants.