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Antisense Oligonucleotide

lademirsen (SAR339375) for Alport Syndrome (HERA Trial)

Phase 2
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up db: from 1st dose of imp upto 1st dose of imp in ole for participant who entered ole (week 48); up to 7 days post last dose for participant not continuing to ole (week 49); ole:1st dose of imp (at week 48) in ole upto 10 weeks post last dose (week 106)
Awards & highlights

HERA Trial Summary

This trial is testing a drug called lademirsen to see if it can help people with Alport syndrome by reducing the decline in renal function. The trial will also look at the safety and tolerability of the drug.

Eligible Conditions
  • Alport Syndrome

HERA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~db: from 1st dose of imp upto 1st dose of imp in ole for participant who entered ole (week 48); up to 7 days post last dose for participant not continuing to ole (week 49); ole:1st dose of imp (at week 48) in ole upto 10 weeks post last dose (week 106)
This trial's timeline: 3 weeks for screening, Varies for treatment, and db: from 1st dose of imp upto 1st dose of imp in ole for participant who entered ole (week 48); up to 7 days post last dose for participant not continuing to ole (week 49); ole:1st dose of imp (at week 48) in ole upto 10 weeks post last dose (week 106) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DB Period: Annualized Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Secondary outcome measures
DB Period: Absolute Change From Baseline in eGFR Values at Week 24 and 48
DB Period: Change From Baseline in Blood Creatinine Values at Weeks 24 and 48
DB Period: Change From Baseline in Blood Cystatine C Values at Weeks 24 and 48
+23 more

HERA Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo/LademirsenExperimental Treatment1 Intervention
Participants received subcutaneous (SC) doses of placebo (matched to lademirsen) every week (QW) during the 48 weeks of double blind (DB) treatment period. Participants who received placebo and completed DB treatment period entered in open-label extension (OLE) treatment period and received lademirsen at a dose of 110 milligrams (mg) QW for an additional 48 weeks (i.e., up to Week 96).
Group II: Lademirsen/LademirsenExperimental Treatment1 Intervention
Participants received SC doses of lademirsen 110 mg QW during the 48 weeks of DB treatment period. Participants who completed DB treatment period entered in OLE treatment period and continued the same lademirsen treatment in OLE period for an additional 48 weeks (i.e., up to Week 96).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,587 Total Patients Enrolled
1 Trials studying Alport Syndrome
4 Patients Enrolled for Alport Syndrome
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,796 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Pediatric NephrologyJournal
Clinical Practice Recommendations for the Diagnosis and Management of Alport Syndrome in Children, Adolescents, and Young Adults–an Update for 2020
Kashtan, Clifford E., and Oliver Gross. 2020. “Clinical Practice Recommendations for the Diagnosis and Management of Alport Syndrome in Children, Adolescents, and Young Adults–an Update for 2020”. Pediatric Nephrology. Springer Science and Business Media LLC. doi:10.1007/s00467-020-04819-6.
clinicaltrials.govStudy
Study of Lademirsen (SAR339375) in Patients With Alport Syndrome
2019. "Study of Lademirsen (SAR339375) in Patients With Alport Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02855268.
~8 spots leftby Apr 2025
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