Using dapagliflozin to treat renal AL amyloidosis

DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

This study is testing if the medication dapagliflozin can help reduce protein levels in the urine of people with renal AL amyloidosis while allowing them to participate from home.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Barbara Ann Karmanos Cancer Institute (other)
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT06420167 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of dapagliflozin, an oral medication, in reducing protein levels in the urine of patients diagnosed with renal AL amyloidosis. The study employs a decentralized design, allowing participants to be screened and monitored remotely through telemedicine. Eligible participants will receive the medication by mail and will be followed up regularly via online consultations and lab work over a six-month period. The trial seeks to determine if dapagliflozin can provide a meaningful reduction in proteinuria for these patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of renal AL amyloidosis and significant proteinuria.

Not a fit: Patients currently undergoing first-line induction therapy for multiple myeloma or with symptomatic multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and quality of life for patients with renal AL amyloidosis.

How similar studies have performed: While the use of dapagliflozin in this specific context is novel, similar studies have shown promise in using SGLT2 inhibitors for renal conditions.

Eligibility criteria

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).

Where this trial is running

Detroit, Michigan

• Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)

Study contacts

• Principal investigator: Jeffrey Zonder, M.D. — Barbara Ann Karmanos Cancer Institute
• Study coordinator: Christiane Houde

Conditions: Renal AL Amyloidosis