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SGLT2 Inhibitor

Dapagliflozin for Kidney Amyloidosis (FLORAL Trial)

Phase 2

Waitlist Available

Led By Jeffery Zonder, M.D.

Research Sponsored by Jeffrey Zonder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Plateau in any renal response (i.e., reduction in proteinuria) for at least 3 months prior to enrollment, as determined by the enrolling physician

Must not have

Baseline eGFR <25 mL/min/1.73m2

Current or previous use of any SGLT2i

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if a pill called dapagliflozin is safe and effective in reducing high protein levels in the urine of patients with renal AL amyloidosis. Participants will be screened

Who is the study for?

This trial is for patients with renal AL amyloidosis, a condition where abnormal proteins build up in the kidneys. Participants must be comfortable using online platforms and telemedicine for screening, consent, instructions, medication delivery, and follow-ups.

What is being tested?

The FLORAL study is testing if dapagliflozin taken orally can lower protein levels in urine of renal AL amyloidosis patients. The trial involves remote monitoring over six months with lab work and side effect assessments at set intervals.

What are the potential side effects?

Potential side effects of dapagliflozin include dehydration, low blood pressure, kidney problems, high cholesterol levels, yeast infections and urinary tract infections. Side effects will be monitored via telemedicine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My kidney condition has not improved for at least 3 months.

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I can care for myself and am up and about more than 50% of my waking hours.

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My kidney disease was confirmed by a biopsy and I have significant protein in my urine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is very low.

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I have used SGLT2 inhibitors for my diabetes.

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I do not have any active cancer needing treatment, except for AL amyloidosis or non-melanoma skin cancers.

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I am being treated for diabetes.

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I have or had symptoms of multiple myeloma, such as bone damage or high calcium levels.

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I do not have severe liver problems like fluid buildup, bleeding veins in my esophagus, or blood clotting issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients achieving 30% reduction in daily proteinuria.

Secondary study objectives

Completion rate of tele-visits

Other study objectives

Incidence rate of developing dialysis dependent ESRD in patients with Pavia Renal AL Stage II or III involvement.

Proportion of patients experiencing any of the following: (1) sustained decline in eGFR, (2) onset of ESRD, or (3) death from a renal disease-related or cardiovascular cause.