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FABHALTA Results

FABHALTA RESULTS

 

FABHALTA clinical study overview

The APPEAR-C3G trial included 74 adults with C3G who had never received a kidney transplant and studied the percentage reduction in urine protein-to-creatinine ratio (UPCR), a test used to measure protein in urine. Urine samples were collected over 24 hours, with results from the start of the study compared against those after 6 months. All patients were receiving a stable dose of maximally tolerated blood pressure medications (ACEi/ARB) with or without other background therapies for 90 days prior to starting the study and throughout the study.

Safety and effectiveness of FABHALTA® in patients with C3G following kidney transplant have not been established.

What Was Studied? (Primary Study Objective)

The reduction in UPCR, a test used to measure protein in the urine (proteinuria), after 6 months of treatment with FABHALTA or placebo.

ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; C3G, complement 3 glomerulopathy.

Clinical study results

FABHALTA SUBSTANTIALLY REDUCED PROTEINURIA COMPARED TO PLACEBO AT 6 MONTHS
-30% FABHALTA vs +8% Placebo

Clinical study details

  • The study included 74 adults with biopsy-confirmed C3G who had never received a kidney transplant. All patients had elevated proteinuria (UPCR ≥1.0 g/g) and eGFR ≥30 mL/min/1.73 m2 at the start of the study and never had a kidney transplant

  • For the first 6 months, 38 people received FABHALTA 200 mg twice daily and 36 people received placebo (sugar pill) twice daily

  • During the next 6 months (extension period), all participants took FABHALTA 200 mg twice daily

eGFR, estimated glomerular filtration rate.

Did you know?

Increasing levels of proteinuria over time is an important indicator that your C3G may be getting worse.

Ask your doctor how FABHALTA can help reduce proteinuria.

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Doctor Discussion Guide

Doctor Discussion Guide

This resource may help you feel prepared before, during, and after your appointment and guide you to have productive conversations with your doctor.
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WITH FABHALTA, PROTEINURIA REDUCTION AT MONTH 6 WAS SUSTAINED THROUGH MONTH 12
Percentage in UPCR (g/g) From Baseline Over 12 Months

In the study, a different measurement was taken to measure protein in the urine (proteinuria) called first morning void (FMV). FMV refers to the first urination of the day after you wake up and is more concentrated at this time.

  • Although there was a numerical improvement at month 6 between FABHALTA and placebo (sugar pill) in the reduction of proteinuria measured by FMV, this may not be attributable to FABHALTA alone and could be due to chance.

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