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DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

Study acronym: FLORAL
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Apr 2026 to Apr 2027
    • Study completion date: Apr 2027 to Apr 2028
    • Site contact updated
    v3
  2. Lead sponsor: Jeffrey Zonder to Barbara Ann Karmanos Cancer Institute
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2024 to Jul 11, 2024
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06420167
Lead Sponsor Barbara Ann Karmanos Cancer Institute
Conditions
(from sponsor)		 Renal AL Amyloidosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov