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New treatment option for Gout and Hyperuricemia
Official title SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
ClinicalTrials.gov ID: NCT06674109
What this study is testing
What is Empagliflozin 10 mg?
Empagliflozin 10 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for gout and hyperuricemia.
Also referred to as Jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 3 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. [History of...
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 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
- Males and females; Age 18-80
- Willingness to adhere to the study intervention procedures.
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
- 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]
- Use of anti-obesity drugs
- Basal-bolus or multiple daily injection insulin regimens, or loop diuretics
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.