See how EMPAVELI performed across 3 key measures

Explore results in people living with C3G or primary IC-MPGN

Meredith, a  real adult who's taken EMPAVELI

Benefits across 3 key measures
Data in children 12+*
Post-transplant recurrent C3G*

*These results represent smaller groups of patients for which the study was not designed to prove results.

Game-changing results across 3 key measures that matter

Doctors track these “key measures” of disease activity to understand how your kidneys are responding to treatment:

Key measure #1Protein in the urine (proteinuria)

Key measure #2Kidney function

Key measure #3C3 fragment buildup in the kidneys

Key measure #1Protein in the urine (proteinuria)

EMPAVELI significantly reduced protein in the urine (proteinuria) at 6 months

Understanding these results

Healthy kidneys help keep protein in the blood and out of the urine. When the kidneys are damaged due to C3G or primary IC-MPGN, protein can leak into the urine (called proteinuria). The VALIANT trial measured proteinuria to evaluate if EMPAVELI could help reduce protein in the urine.

Primary goal

Game-changing proteinuria reduction

High protein in your urine is a sign your kidneys aren’t working well. EMPAVELI significantly lowered proteinuria, which can help slow disease progression.

Kerry, the mother of Quinn who's taken EMPAVELI

“Since Quinn started EMPAVELI, we saw an improvement in his labs...specifically, his
uPCR was significantly reduced. It was surprising and a huge relief all at the same time.”

Individual experiences may vary.

Consistent results lasting 1 year

Patients taking EMPAVELI for 1 year1 yearAfter the first part of the study (lasting 6 months), all patients received EMPAVELI, and both patients and researchers knew they were receiving EMPAVELI. The results shown include up to 1 year of data from this part of the study. had clinically meaningful and sustained reductions in proteinuria

After 6 months, all participants in the trial received EMPAVELI for an
additional 6 months.

People taking EMPAVELI experienced proteinuria reduction that was maintained throughout 1 year.

After switching from placebo to EMPAVELI, reduction in protein in the urine was also observed but slightly less than what was seen in people who had been taking EMPAVELI from the beginning of the study.

People in this group received placebo for the first 6 months, during which proteinuria increased by 3%. After switching to EMPAVELI, proteinuria was 51% lower than at the start of the study (baseline) at 1 year.

Ready to talk with your doctor about EMPAVELI?

Get your personalized Doctor Discussion Guide to help you make the most of your next appointment.

Get started

Key measure #2Kidney function

People taking EMPAVELI maintained their kidney function at 6 months

Understanding these results

To better understand how the kidneys were working, the VALIANT trial looked at whether kidney function stayed stable defined as eGFReGFREstimated glomerular filtration rate, or eGFR, is an estimate that shows how well your kidneys are filtering waste. A higher number means better kidney function. reduction of 15% or less and whether protein in the urine was reduced by 50% or more with EMPAVELI. They assessed each of these outcomes on their own, as well as how many people achieved both.

Secondary goals

Stabilized kidney function

Kidney composite
endpoint

Nearly half of people saw both stabilization of kidney functionStabilized kidney function/Stabilization of kidney functionStabilization of kidney function was defined as an eGFR reduction of 15% or less. This shows a slower decline in kidney function. and reduction of proteinuriaReduced proteinuria/Reduction of proteinuria:Reduction of proteinuria of 50% or more, indicating less protein is leaking into the urine. at 6 months with EMPAVELI (31 out of 63 people)

compared to 3% of the placebo group  (2 out of 61 people)^†

eGFR stabilization

Most people had stable kidney function as measured by eGFR at 6 months with EMPAVELI (43 out of 63 people)

compared to 59% of the placebo group
(36 out of 61 people)

Proteinuria reduction

Most people had 50% or more reduction in proteinuria at 6 months with EMPAVELI (38 out of 63 people)

compared to 5% of the placebo group
(3 out of 61 people)

^†Kidney composite endpoint. The kidney composite endpoint combines multiple individual indicators of kidney function and disease progression into a single study goal.

EMPAVELI reduced the loss of kidney function over 6 months

Difference in eGFR of
+6.31 mL/min/1.73 m²
between EMPAVELI and placebo
at 6 months

eGFR measures how well your kidneys function. EMPAVELI has been shown to help slow disease progression to protect kidney function.

Kidney function results over 1 year

Change in kidney function (measured by eGFR) compared to baseline

Understanding these results

Most people experience some loss in kidney function as they age. In people with C3G or primary IC-MPGN, this loss can happen more quickly. Reducing the loss of kidney function is an important treatment goal.

EMPAVELI helps to slow down how fast your kidneys lose function with results seen over 1 year.

People taking EMPAVELI
months 1-6

(n=63 patients)

Reduction in the loss of
kidney function

People taking placebo
months 1-6

(n=61 patients)

Declined kidney
function

People who switched to
EMPAVELI months 6-12

(n=57 patients)

Reduction in the loss of
kidney function

See full study results Go back

Difference in eGFR of +6.31 mL/min/1.73 m² between EMPAVELI and placebo at 6 months

EMPAVELI is a strong move you can make to help reduce the loss of kidney function and slow disease progression

Key measure #3C3 fragment buildup in the kidneys

EMPAVELI reduced C3 fragment buildup at 6 months

Understanding these results

C3 fragments can build up in the kidneys and contribute to inflammation and kidney damage. The VALIANT trial measured C3 fragment levels to understand how EMPAVELI was working on the underlying disease process. This result shows the effect of EMPAVELI on the body and was not a primary or secondary goal of the study.

Pharmacodynamic results^‡

Of the 69 people with kidney biopsies^§, 74% of people (26 out of 35) taking EMPAVELI had reduced C3 fragmentsReduced C3 fragmentsReduced C3 fragment levels may be a sign that the disease is becoming less active. by at least 2 intensity levels at 6 months compared to 12% of the placebo group (4 out of 34)

Week 26

Baseline

For illustrative purposes only.

More C3 staining data

71.4% of adults (25 out of 35) had no C3 fragments detectedNo C3 fragments detectedThis means no signs of C3 fragment buildup were detected in the kidney biopsy. at 6 months compared to 8.8% of the placebo group (3 out of 34)

What do intensity levels mean?

Intensity levels reflect how much C3 is present.

The higher your intensity reduction is, the clearer your kidneys become of C3 fragments.

1-level intensity reduction=10x fewer C3 fragments

2-level intensity reduction=100x fewer C3 fragments

3-level intensity reduction=No detectable C3 fragments

Kidney biopsies from a person with post-transplant recurrent C3G. Images courtesy of Patrick D. Walker, MD, Senior Renal Pathologist at Arkana Laboratories.
^‡Pharmacodynamic data help researchers understand how a medicine affects the body.
^§Evaluable patients included only adult patients. Kidney biopsies were not performed on pediatric patients.

C3 staining shows C3 fragment buildup in the kidneys, which can indicate ongoing disease activity. EMPAVELI reduces C3 fragment buildup in the kidneys.

Key measure #1Protein in the urine (proteinuria)

Key measure #2Kidney function

Key measure #3C3 fragment buildup in the kidneys

Meredith, a real adult who’s taken EMPAVELI

“I noticed a difference after using EMPAVELI. I started to feel like myself again—for the first time in years. My labs reflected the change, and my numbers started improving.”

Individual experiences may vary.

EMPAVELI is a strong move you can make to stabilize kidney function and slow disease progression

Meredith, a real adult who’s taken EMPAVELI

Results seen in a smaller group of children and teens aged 12 to 17 years

These results are based on a small group and are considered to be exploratory because the
study was not designed to show differences between EMPAVELI and placebo within these groups
of patients. More research is needed to better understand them.

Children and teens had less protein in the urine at 6 months

From Day 1 to 6 months

Children and teens who achieved the kidney composite endpoint (measured by eGFR reduction of 15% or less) along with lower protein in the urine by 50% or more at 6 months^†

Over half (57.1%) of children
and teens achieved the kidney
composite endpoint with EMPAVELI
(n=28 patients)

compared with 3.7% with placebo

(n=27 patients)

^†Kidney composite endpoint. The kidney composite endpoint combines multiple individual indicators of kidney function and disease progression into a single endpoint.

Children and teens saw a change in eGFR at 6 months

Difference in eGFR of
+9.7 mL/min/1.73 m²
between EMPAVELI and
placebo at Week 26

Ready to talk to your child’s doctor about EMPAVELI?

Get your personalized Doctor Discussion Guide to help you make the most of your next appointment.

Get started

EMPAVELI showed results from a smaller group of people whose C3G returned after a kidney transplant (recurrent C3G)

These results are based on a small group and are considered to be exploratory because the study was not designed to show differences between EMPAVELI and placebo within these groups of patients. More research is needed to better understand them.

People with recurrent C3G following a kidney transplant had less protein in the urine at 6 months

From Day 1 to 6 months

People with recurrent C3G following a kidney transplant who achieved the kidney composite endpoint (measured by eGFR reduction of 15% or less) and lower protein in the urine by 50% or more at 6 months^†

60% of people achieved
the kidney composite endpoint by
Week 26 with EMPAVELI

(n=5 patients)

compared with 0% with placebo

(n=4 patients)

^†Kidney composite endpoint. The kidney composite endpoint combines multiple individual indicators of kidney function and disease progression into a single endpoint.

Change in eGFR observed at Week 26

Difference in eGFR of
+9.3 mL/min/1.73 m²
between EMPAVELI and
placebo at Week 26

Safety, effectiveness, and pharmacodynamic data of EMPAVELI in patients with recurrent primary IC-MPGN following kidney transplant have not been established.

Pharmacodynamic result^||

All patients whose C3G returned following a kidney transplant had reduced C3 staining by at least 2 intensity levels (orders of magnitude) at 6 months with EMPAVELI

100% achieved reduced C3
fragment detection^¶ by Week 26
with EMPAVELI
(4 out of 4)

compared with 25% with placebo

(1 out of 4)

These data are based on an additional analysis of pharmacodynamic data. They were not powered to detect differences between treatment and placebo in these data, and results were not included in the study’s formal multiplicity-controlled testing hierarchy. Therefore, findings should be considered exploratory and interpreted descriptively. No formal statistical conclusions can be drawn.

^||Pharmacodynamic data help researchers understand how a medicine affects the body.
^¶In adults with evaluable baseline and 6-month kidney biopsies.

Safety, effectiveness, and pharmacodynamic data of EMPAVELI in patients with recurrent IC-MPGN following kidney transplant have not been established.

Still wondering if EMPAVELI is right for you?

Becks, a Patient Engagement Team member

A Patient Engagement Team member can help point you in the right direction for additional resources and answers.

Get answers

Alyssa, a  real teen who’s taken EMPAVELI

Alyssa,  a real teen who’s taken EMPAVELI

Hear from others taking EMPAVELI Learn about safety with EMPAVELI

C3G=C3 glomerulopathy; eGFR=estimated glomerular filtration rate; IC-MPGN=immune-complex membranoproliferative glomerulonephritis; uPCR=urine protein-to-creatinine ratio.

See how EMPAVELI performed across 3 key measures