DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

NCT06420167 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2023-074
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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

Renal AL Amyloidosis

Outcome Measures

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.

  Up to Month 6

Secondary Outcomes (1)

• Completion rate of tele-visits

  Up to Month 6

Other Outcomes (2)

• 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.

  Up to Month 6

• Incidence rate of developing dialysis dependent ESRD in patients with Pavia Renal AL Stage II or III involvement.

  Up to Month 6

Study Arms (1)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10mg orally, daily for 6 months

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

10mg orally once daily

Also known as: BMS-512148, Forxiga® / Farxiga®

Dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Jeffrey Zonder, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Houde

CONTACT

3135768673; Houdec@karmanos.org

Jeffrey Zonder, M.D.

CONTACT

3135768732; zonderj@karmanos.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Multiple Myeloma Multidisciplinary team leader, M.D.

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: July 11, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)