ClinicalTrials.gov record NCT06420167

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 trial gives oral dapagliflozin 10 mg daily for six months to people with renal AL amyloidosis and proteinuria. The study is decentralized: screening, consent, and most visits are remote, medication is mailed, and local labs are used. Participants are followed with telemedicine and lab checks around 1, 3 and 6 months.

What it is studying. The study is testing whether daily dapagliflozin is safe for people with renal AL amyloidosis and whether it leads to a 30% or greater reduction in 24‑hour albuminuria within six months. The study also tracks tele-visit completion and other safety data during treatment.

What the researchers hope to learn. To measure the proportion of participants who achieve a 30% reduction in 24-hour albuminuria within six months of starting dapagliflozin; to collect safety data on dapagliflozin in this population; and to assess tele-visit completion in a decentralized study design.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Dapagliflozin

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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).

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry
  • 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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Screening and consent are handled online; you'll meet the investigator virtually to review medical history and performance status. Local laboratory tests will be ordered (results faxed to the study site) and participants receive study medication by mail. You will take dapagliflozin 10 mg orally once daily for 6 months, complete telemedicine visits and online check-ins, and have lab monitoring and side-effect checks at about 1, 3 and 6 months (additional labs if clinically needed). Pill diaries and empty pill bottles are returned by mail using the provided envelope.

How the study is structured. Interventional Phase 2, single-group, open-label study. Everyone enrolled receives dapagliflozin 10 mg orally once daily for six months. The trial uses a decentralized approach: online prescreening and electronic consent, virtual visits/telemedicine, medication mailed from the site pharmacy, and local laboratory testing at baseline and follow-up (about 1, 3 and 6 months). There is no randomization or masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 11, 2024
Primary completion
April 2027 (estimated)
Study completion
April 2028 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Jun 26, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Barbara Ann Karmanos Cancer Institute
Principal investigator
Jeffrey Zonder, Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D.
Barbara Ann Karmanos Cancer Institute

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
Baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
follow up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
concomitant medications
Other medicines a participant takes during the study. Some must be reported; some are restricted.
screening visit
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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