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Anti-fibrotic agent

Vonafexor for Alport Syndrome (ALPESTRIA-1 Trial)

Phase 2
Recruiting
Research Sponsored by Enyo Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has eGFR between ≥ 30 and < 90 ml/min/1.73m2
Has confirmed diagnosis of Alport syndrome: clinical diagnosis (haematuria, family history, hearing loss, ocular change) OR a kidney biopsy showing glomerular basement membrane abnormalities consistent with AS, AND Genetic confirmation of AS
Must not have
Is taking CYP3A4/5 inhibitors or inducers
Has moderate or severe hepatic impairment (Child-Pugh score B or C)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
Awards & highlights

Summary

"This trial is testing how safe vonafexor is and how it affects kidney function in people with Alport syndrome who are at risk of their condition getting worse."

Who is the study for?
This trial is for people with Alport syndrome at risk of kidney function decline. Participants must have certain levels of kidney function, no hepatitis B/C or HIV, use contraception if applicable, and be on stable treatments for related conditions. Pregnant individuals or those with recent serious illnesses are excluded.
What is being tested?
The study tests the safety and impact of vonafexor on kidney function in Alport syndrome patients. It's a proof-of-concept trial to see how well this drug works and what effects it has on those who might face worsening kidney health.
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions to vonafexor which could include typical drug responses such as digestive issues, allergic reactions, changes in liver enzymes or other organ-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by eGFR, is between 30 and 90 ml/min.
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I have been diagnosed with Alport syndrome through symptoms, kidney biopsy, and genetic testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication that affects liver enzymes.
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My liver function is significantly impaired.
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I have not had any active cancer in the past year.
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I haven't had any major illnesses or conditions in the last 30 days that could affect my participation.
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My LDL cholesterol is high, putting me at risk for heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and during on-treatment (assessed up to 24 weeks) and off-treatment periods (assessed up to 36 weeks) compared to baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Treatment-Emergent Adverse Event (TEAE)
Secondary outcome measures
Change in eGFR
Vonafexor plasma concentrations
Other outcome measures
Change in Neutrophil Gelatinase Associated Lipocalin (NGAL)
Change in albuminuria
Change in proteinuria

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT03812029
67%
Pruritus
15%
Nausea
12%
Diarrhoea
9%
Limb injury
9%
Hypercholesterolaemia
6%
Skin lesion
6%
Vomiting
6%
Depression
6%
Insomnia
6%
Transaminases increased
6%
Headache
3%
Constipation
3%
Urinary tract infection
3%
Cough
3%
Paraesthesia
3%
COVID-19
3%
Hypertension
3%
Abdominal pain
3%
Abdominal rigidity
3%
Type 2 diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vonafexor 200 mg QD Part B
Vonafexor 100 mg QD Part B
Placebo Part A
Vonafexor 100 mg BID Part A
Vonafexor 200 mg QD Part A
Vonafexor 400 mg QD Part A
Placebo Part B

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm fixed dose escalationExperimental Treatment1 Intervention
This is a single arm fixed dose escalation with three dose levels of vonafexor, all QD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vonafexor
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Enyo PharmaLead Sponsor
9 Previous Clinical Trials
368 Total Patients Enrolled
~13 spots leftby Jul 2025
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