Actively Recruiting
Dapagliflozin in Renal AL Amyloidosis (FLORAL) Oral Treatment Study for Proteinuria Reduction
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2025-01-09
20
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an oral drug called dapagliflozin in reducing high protein levels in the urine of patients with renal amyloid light-chain (AL) amyloidosis. This Phase 2 clinical trial uses a decentralized design to allow participants to join and be monitored remotely. The study focuses on patients with a confirmed diagnosis of renal AL amyloidosis and significant proteinuria. Participants will receive dapagliflozin at a dose of 10 mg once daily by mouth for six months. The study involves online screening, electronic consent, and virtual visits. Medication and study supplies, including a pill diary and weighing scale if needed, are sent by mail. Participants are followed up at 1, 3, and 6 months via telemedicine or other online methods to assess treatment adherence, side effects, and lab results. During the study, participants undergo laboratory testing at local labs covered by their insurance. Researchers monitor proteinuria levels and other safety measures regularly. The main outcome is the proportion of patients achieving at least a 30% reduction in daily proteinuria by month 6. The study team also tracks medication compliance through pill counts or diaries and manages any necessary additional lab tests for safety. The total treatment period lasts six months with ongoing remote follow-up.
CONDITIONS
Official Title
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with study procedures including remote telehealth visits and use of mobile/web apps.
- Age 18 years or older.
- Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy.
- Proteinuria greater than 1.0 gram per day without other identifiable causes.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
- Stable renal response plateau (no proteinuria reduction) for at least 3 months before enrollment.
- Residence in the state of Michigan.
You will not qualify if you...
- Currently undergoing first line induction or post-induction maintenance anti-plasma cell therapy for less than 6 months.
- Diagnosis of symptomatic multiple myeloma or related severe plasma cell disorders.
- Women of child-bearing potential not using reliable contraception or who are pregnant or breastfeeding.
- Known allergies to dapagliflozin components.
- Treatment for type 1 or type 2 diabetes mellitus.
- Baseline estimated glomerular filtration rate (eGFR) less than 25 mL/min/1.73m2.
- Severe acute or chronic liver disease.
- Current or previous use of any SGLT2 inhibitors.
- Recent initiation or dose changes of ACE inhibitors or ARBs within 3 months.
- Active malignancy requiring treatment, excluding AL amyloidosis and non-melanoma skin cancers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
C
Christiane Houde
J
Jeffrey Zonder, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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