DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
ConditionRenal AL Amyloidosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Ann Karmanos Cancer Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Either ongoing first line induction with anti-plasma cell therapy or ongoing post- induction maintenance for <6 months prior to enrollment.
Diagnosis of symptomatic multiple myeloma, including presence of lytic bone disease, plasmacytomas, ≥60% plasma cells in the bone marrow, or hypercalcemia, either currently or in the past.
Women of child-bearing potential (i.e., those who have not undergone chemical or surgical sterilization or are not postmenopausal) and who are unwilling to use a medically accepted and reliable form of contraception while participating in the study and for 2 weeks following the last dose of study medication, as determined by the investigator, or have a positive pregnancy test at the time of enrolment or are currently breastfeeding.
Known allergic reactions to components of the dapagliflozin.
Trial design
Design model
Single group
Treatments tested in this trial
Dapagliflozin
Drug10mg orally once daily
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: DapagliflozinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients achieving 30% reduction in daily proteinuria.
A patient will be considered to have achieved the desired urine protein reduction if a 30% reduction in 24-hour albuminuria occurs at any point during the six-month period from the initiation of dapagliflozin therapy. The proportion of patients achieving this reduction will be calculated as the ratio of the total number of patients who experienced the reduction to the total number of evaluable patients.
Time frame
Up to Month 6Secondary outcomes
1
Completion rate of tele-visits
The completion rate of tele-visits, including post-trial feedback, will be calculated as the ratio of completed tele-visits to scheduled tele-visits.
Time frame
Up to Month 6Other outcomes
1
Proportion of patients experiencing any of the following: (1) sustained decline in eGFR, (2) onset of ESRD, or (3) death from a renal disease-related or cardiovascular cause.
A patient's status will be recorded as 'yes' if any of the following three events occur at any time during the 6 months of study therapy: a sustained ≥50% decline in estimated glomerular filtration rate (eGFR); the onset of dialysis-requiring end- stage renal disease (ESRD); or death from a renal disease-related or cardiovascular cause. Otherwise, the status will be marked as 'no'.
Time frame
Up to Month 62
Incidence rate of developing dialysis dependent ESRD in patients with Pavia Renal AL Stage II or III involvement.
The onset of ESRD in patients with Pavia Renal Stage II or III involvement will be recorded as binary (yes vs. no).
Time frame
Up to Month 6Sponsors and contacts
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Source ClinicalTrials.gov