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DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

NCT06420167 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-09

No results posted yet for this study

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

Interventions

DRUG

Dapagliflozin

10mg orally once daily

Sponsors & Collaborators

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Jeffrey Zonder, M.D. · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06420167 on ClinicalTrials.gov