DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
Barbara Ann Karmanos Cancer Institute
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 * 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
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. 2. If appropriate based on answers to the questions, the participant may provide their contact information for follow up by the study team. 3. Study team contacts potential participants to review the study and explain next steps 4. Participant is provided with the link and password to view the video and sign th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 protei…
Interventions
- DrugDapagliflozin
10mg orally once daily
Location
- Karmanos Cancer InstituteDetroit, Michigan