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Antisense Oligonucleotide

RG012 Every Other Week for Alport Syndrome

Phase 1
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.

Eligible Conditions
  • Alport Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of RG-012 on renal microRNA-21 (miR-21)
Safety - Adverse Events
Secondary outcome measures
Pharmacokinetic (PK) parameter - AUC
Pharmacokinetic (PK) parameter - Cmax
Pharmacokinetic (PK) parameter - Tmax

Trial Design

2Treatment groups
Experimental Treatment
Group I: RG012 Every Other WeekExperimental Treatment1 Intervention
1.5 mg/kg RG012 subcutaneous injections every other week
Group II: RG-012 Single DoseExperimental Treatment1 Intervention
1.5 mg/kg RG012 subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RG012
2017
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,616 Total Patients Enrolled
1 Trials studying Alport Syndrome
43 Patients Enrolled for Alport Syndrome
Clinical Sciences & Operations, M.D.Study DirectorSanofi

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
clinicaltrials.govStudy
A Study of RG-012 in Subjects With Alport Syndrome
2017. "A Study of RG-012 in Subjects With Alport Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03373786.
~1 spots leftby May 2025
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