Using dapagliflozin to treat renal AL amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Houdec@karmanos.org
• Phone: 3135768673

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Hungarian National Systemic Amyloidosis Registry

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• How the IGLV1-44 light chain causes AL amyloidosis and POEMS

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• Belgian Amyloidosis Biobank and Patient Registry at UZ Leuven

  This project collects and stores blood, tissue samples, and medical data from adults with suspected or confirmed amyloidosis to create a biobank and registry for future research.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.