Recruiting
Phase 2

DapagliFLOzin

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT06420167

Conditions

Renal AL Amyloidosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dapagliflozin

Study Details

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

Study ID

NCT06420167

Start date

Jul 11, 2024

Status verified date

Jun, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dapagliflozin

Dapagliflozin 10mg orally, daily for 6 months

Interventions

Dapagliflozin

10mg orally once daily

Primary outcome measure

  • Proportion of patients achieving 30% reduction in daily proteinuria. [ Time Frame: Up to Month 6 ]

Central Contacts and Locations

Central contacts

Christiane Houde

3135768673Houdec@karmanos.org

Jeffrey Zonder, M.D.

3135768732zonderj@karmanos.org

Locations

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Christiane Houde

3135768673Houdec@karmanos.org

Jeffrey Zonder

3135768732zonderj@karmanos.org

Principal Investigator:

Jeffrey Zonder, M.D.

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2026-06-26.