Dapagliflozin to Reduce the Decline in Renal Function in Patients Newly Diagnosed With Lupus Nephritis (NCT07678203)
Dapagliflozin Reduces the Progression of Chronic Kidney Disease in Lupus Nephritis: Phase II Trial.
🩺 Plain-English Summary (8th-Grade Level)
Lupus nephritis is one of the most serious complications of lupus, an autoimmune disease in which the immune system mistakenly attacks the body's own tissues. This condition causes inflammation and damage to the kidneys and is a major cause of chronic kidney disease, especially in the Latin American population. In these patients, the disease often appears at a younger age, presents with more intense inflammation, and has a more aggressive course. Although treatments exist that help control the immune response and reduce kidney damage, a significant proportion of patients do not achieve sustained kidney recovery. As a result, protein loss in the urine persists, and kidney function continues to deteriorate over time. Given this situation, new therapeutic alternatives have emerged aimed at protecting kidney function. Among them is dapagliflozin, a medication that has shown benefits in various types of chronic kidney disease by helping to lower pressure within the kidneys, reduce inflammation, and limit the formation of scar tissue. However, there is still limited information on its effectiveness in people with active lupus nephritis. The objective of this study is to evaluate the efficacy and safety of dapagliflozin in preventing the progression of chronic kidney disease in patients with lupus nephritis. The results will generate scientific evidence to help improve renal protection strategies in this population. To this end, a phase II, open-label, controlled, randomized clinical trial will be conducted in adult patients newly diagnosed with lupus nephritis treated at the Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". Participants will be randomly assigned in a one-to-one ratio to two groups: one will receive standard treatment plus dapagliflozin (10 mg daily), and the other will receive only standard treatment. For three months, the amount of protein excreted in urine, renal function, and progression to chronic kidney disease will be evaluated. In addition, potential adverse effects, changes in lupus activity, and variables related to the prevention of cardiovascular, renal, and metabolic diseases will be recorded.
Who can join: Review the eligibility criteria below.
Location: Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". — Guadalajara, Jalisco
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Nuevo Hospital Civil de Guadalajara "Dr. Juan I. Menchaca". — Guadalajara, Jalisco
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Nephritis (LN)
- Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis — Rochester, Minnesota
- Safety and Efficacy of ONT01 in Lupus — New York, New York
- Dapagliflozin in Active Lupus Nephritis — Boston, Massachusetts
Explore by condition: All Lupus Nephritis (LN) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.