drugset / Trial / NCT06420167

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

NCT06420167

Phase 2 Recruiting 20 enrolled Barbara Ann Karmanos Cancer Institute
NaSingle-groupOpen-labelTreatment

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

Timeline

Start
2024-07-11
Primary completion
2027-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dapagliflozin Small molecule 10 mg Oral

Indications