DapagliFLOzin in Renal AL Amyloidosis (FLORAL)

Conditions

• Renal AL Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dapagliflozin — DRUG
  10mg orally once daily

Study Details

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

Key Dates

Start date

Jul 11, 2024

Status verified

Jan 2025

Primary completion

Apr 30, 2026

Completion

Apr 30, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dapagliflozin
  Dapagliflozin 10mg orally, daily for 6 months

Primary Outcome Measure

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

Central Contacts

• Christiane Houde
  3135768673
  [email protected]
• Jeffrey Zonder, M.D.
  3135768732
  [email protected]

Locations (1)

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