Phase
Condition
Amyloidosis
Treatment
Dapagliflozin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provision of signed and dated informed consent form.
Stated willingness to comply with study procedures, including remote telehealthconsultations with the study team, confirming availability, and agreeing to usemobile/web applications for study purposes.
Age ≥18 years.
Histopathologic diagnosis of renal AL amyloidosis confirmed by biopsy of any tissueand 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 monthsprior to enrollment, as determined by the enrolling physician.
Residence in the state of Michigan.
Exclusion
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, eithercurrently or in the past.
Women of child-bearing potential (i.e., those who have not undergone chemical orsurgical sterilization or are not postmenopausal) and who are unwilling to use amedically accepted and reliable form of contraception while participating in thestudy and for 2 weeks following the last dose of study medication, as determined bythe investigator, or have a positive pregnancy test at the time of enrolment or arecurrently 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 (ACEinhibitors) and angiotensin receptor blockers (ARBs) <3 months prior to enrollment.
Active malignancy requiring treatment (other than AL amyloidosis and non-melanomaskin cancers).
Study Design
Study Description
Connect with a study center
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting

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