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RG012

Phase 1

Alport Syndrome | Small molecule | Nephrology |Sanofi|Last Updated: Apr 25, 2022

Success Probability

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Market & Valuation

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Trial Design

Double-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

RG012 · 1 trial · 1 indication

Phase 1 1
NCT03373786A Study of RG-012 in Subjects With Alport SyndromeAlport Syndrome
COMPLETED4 Analytics
PHASE1COMPLETED
A Study of RG-012 in Subjects With Alport Syndrome
Alport SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety - Adverse Events
8 weeks

Incidence and severity of adverse events

Effect of RG-012 on renal microRNA-21 (miR-21)
8 weeks

Change in miR-21 expression in renal tissue

Secondary Endpoints

Pharmacokinetic (PK) parameter - Cmax
8 weeks
Pharmacokinetic (PK) parameter - Tmax
8 weeks
Pharmacokinetic (PK) parameter - AUC
8 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RG-012 Single DoseEXPERIMENTAL1.5 mg/kg RG012 subcutaneous injection
RG012 Every Other WeekEXPERIMENTAL1.5 mg/kg RG012 subcutaneous injections every other week

Interventions

NameTypeDescription
RG012DRUGRG012 in 0.3% sodium chloride
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: 1. Males or females, ages 18 to 65 years 2. Confirmed diagnosis of Alport syndrome 3. eGFR between 40 and 90 mL/min/1.73m2 4. Proteinuria of at least 300 mg protein/g creatinine 5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 3...

Countries:United States
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Frequently asked questions about RG012

What is RG012 used for in Alport Syndrome?

RG012 is an investigational small molecule being developed for the treatment of Alport Syndrome, a genetic condition affecting the kidneys. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RG012?

RG012 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical trials for Alport Syndrome.

What phase is RG012 in?

RG012 is in Phase 1 clinical development. A Phase 1 study of RG012 in subjects with Alport Syndrome has been completed, but the drug remains investigational and has not received regulatory approval.

What clinical trials is RG012 in?

RG012 has one completed clinical trial, NCT03373786, titled "A Study of RG-012 in Subjects With Alport Syndrome." This Phase 1 study enrolled 4 participants in the United States and was a double-blind, controlled trial.

Is RG012 the same as RG-012?

Yes, RG012 is also referred to as RG-012 in clinical trial documentation. The completed Phase 1 study, NCT03373786, uses the name RG-012 in its title, confirming that both names refer to the same investigational drug.