DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Contact Information
Primary
Christiane Houde
Houdec@karmanos.org
3135768673
Backup
Jeffrey Zonder, M.D.
zonderj@karmanos.org
3135768732
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2027-04
Participants
Target number of participants: 20
Treatments
Experimental: Dapagliflozin
Dapagliflozin 10mg orally, daily for 6 months
Related Therapeutic Areas
Sponsors
Leads: Barbara Ann Karmanos Cancer Institute

This content was sourced from clinicaltrials.gov