Actively Recruiting
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
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
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
Research Team
C
Christiane Houde
CONTACT
J
Jeffrey Zonder, M.D.
CONTACT
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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