DapagliFLOzin in Renal AL Amyloidosis (FLORAL) (NCT06420167)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if an oral drug called dapagliflozin is safe and can reduce high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis using a decentralized study design. Participants will be: * screened for the trial via an online platform * contacted by study personal to obtain electronic consent * enrolled in the trial if eligible and consented * contacted by study personal for further instructions and directions * sent dapagliflozin oral medication (supplied by the site pharmacy) * followed up regularly with the study team via telemedicine or other online avenues * monitored using lab work, inquiries about side effects and assessment of protocol adherence at 1 month, 3 months and 6 months * continue treatment for 6 months
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (11 items).
Location: Karmanos Cancer Institute — Detroit, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for \<6 months prior to enrollment.
- Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past.
- Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding.
- Known allergic reactions to components of the dapagliflozin.
- Treatment requiring type 1 or type 2 diabetes mellitus.
- Baseline eGFR \<25 mL/min/1.73m2.
- Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy)
- Current or previous use of any SGLT2i.
- Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) \<3 months prior to enrollment.
- Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Karmanos Cancer Institute — Detroit, Michigan
📞 Contact the Study Coordinator
Phone: (313) 576-8673
Email: Houdec@karmanos.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
Explore by condition: All Renal AL Amyloidosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.