Renal AL AmyloidosisPhase 2FLORALNCT06420167
DapagliFLOzin in Renal AL Amyloidosis (FLORAL)
A Phase 2 study testing Dapagliflozin in people with Renal AL Amyloidosis, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal AL Amyloidosis
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2024to Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Treatment requiring type 1 or type 2 diabetes mellitus.
- Baseline eGFR <25 mL/min/1.73m2.
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- Acute or chronic liver disease with severe impairment of liver function (e.g., ascites, esophageal varices or coagulopathy)
- Current or previous use of any SGLT2i.
- Initiation or dose modification of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) <3 months prior to enrollment.
- Active malignancy requiring treatment (other than AL amyloidosis and non-melanoma skin cancers).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Christiane Houde, 3135768673, Houdec@karmanos.org
Jeffrey Zonder, 3135768732, zonderj@karmanos.org
About this study
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
Read the detailed description
- Participants are recruited by one of the following methods:
- Self-referral through the website
- Receiving recruitment materials from their provider.
- Participant visits the prescreening website.
- High level prescreening questions are answered by the participant.
- If appropriate based on answers to the questions, the participant may provide their contact information for follow up by the study team.
- Study team contacts potential participants to review the study and explain next steps
- Participant is provided with the link and password to view the video and sign the consent via Adobe Sign
- An investigator will meet virtually with the participant to obtain medical history information, concomitant medications, and performance status (screening visit)
- Once the participant passes screening in step 5, an order will be sent to the participant for the remaining screening labs to be done at a local laboratory that is covered by their insurance
- The lab will fax results to the site
- After review of eligibility and the study team will proceed with enrolling the participant if appropriate
- The participant will proceed to the baseline visit (telehealth for any portion that can be done via phone/video and order for lab tests as previously described) if needed to comply with the protocol calendar/window.
- The participant is approved to begin dosing by the investigator
- The site will dispense via mail the following:
- 4 month's supply of Dapagliflozin
- A self-addressed envelope for return of the diary and pill bottles at the end of the dosing period
- A weighing scale (if required)
- Dosing compliance will be checked during initial study treatment via sharing of pill accountability data or screenshot of paper pill diary
- If clinically indicated, labs will be ordered and run more frequently to assess for toxicity.
- Visits 3, 4, and 5 will be conducted in the same manner as described above.
- All pill bottles and diaries (if paper version is used) will be returned via the provided envelope
- Conditions
- Renal AL Amyloidosis
- Being tested
- Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called BMS-512148, Forxiga® / Farxiga®
10mg orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin 10mg orally, daily for 6 months Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Month 6
Secondary 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.
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start11 Jul 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal AL AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Zonder, Barbara Ann Karmanos Cancer Institute
- Investigators
- Jeffrey Zonder, M.D., Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420167
- Sponsor's protocol ID
- 2023-074
- Acronym
- FLORAL
- Status last verified
- Jun 2026
- First submitted
- 14 May 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No