DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
- Registration Number
- NCT06420167
- Lead Sponsor
- Jeffrey Zonder
- Brief Summary
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
...
- Detailed Description
1. Participants are recruited by one of the following methods:
1. Self-referral through the website
2. Receiving recruitment materials from their provider.
2. Participant visits the prescreening website.
1. High level prescreening questions are answered by the participant.
...
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Provision of signed and dated informed consent form.
- Stated willingness to comply with study procedures, including remote telehealth consultations with the study team, confirming availability, and agreeing to use mobile/web applications for study purposes.
- Age ≥18 years.
- Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissue and evidence of >1.0 g/day proteinuria without any other identifiable cause.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.
- Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician.
- Residence in the state of Michigan.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dapagliflozin Dapagliflozin Dapagliflozin 10mg orally, daily for 6 months
- Primary Outcome Measures
Name Time Method Proportion of patients achieving 30% reduction in daily proteinuria. Up to Month 6 A patient will be considered to have achieved the desired urine protein reduction if a 30% reduction in 24-hour albuminuria occurs at any point during the six-month period from the initiation of dapagliflozin therapy. The proportion of patients achieving this reduction will be calculated as the ratio of the total number of patients who experienced the reduct...
- Secondary Outcome Measures
Name Time Method Completion rate of tele-visits Up to Month 6 The completion rate of tele-visits, including post-trial feedback, will be calculated as the ratio of completed tele-visits to scheduled tele-visits.
Trial Locations
- Locations (1)
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States