Study of RG-012 in Male Subjects With Alport Syndrome (HERA)
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|ClinicalTrials.gov Identifier: NCT02855268|
Recruitment Status : Suspended (Sponsor Decision)
First Posted : August 4, 2016
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alport Syndrome||Drug: RG-012 Drug: Placebo||Phase 2|
This is a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study of RG-012 in male subjects with Alport syndrome. Eligible subjects will be randomized in a 1:1 ratio to receive subcutaneous (SC) injections of RG-012 or placebo every other week for 48 weeks. After completion of this double-blind treatment period, subjects will have the opportunity to receive RG-012 in a 48 week open-label extension period.
Male subjects with a confirmed diagnosis of Alport syndrome and a baseline GFR between 40 and 90 mL/min/1.73m2 will be eligible for enrollment. Subjects may enter this study directly or may enroll after participation in the RG012-01 ATHENA Natural History Study.
Subjects may continue treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), but must be on a stable dosing regimen for the 30 days prior to screening.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RG-012 for Injection in Subjects With Alport Syndrome|
|Actual Study Start Date :||November 7, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
1.5 mg/kg subcutaneous injection
RG-012 in 0.3% sodium chloride
Other Name: Active
|Placebo Comparator: Placebo||
matching placebo for injection
- Safety and tolerability [ Time Frame: 48 Weeks ]Assessed by the frequency and severity of adverse events (AEs) and changes in laboratory parameters, vital signs, and ECGs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855268
Show 23 Study Locations
|Study Director:||Mark Deeg, M.D.||Regulus Therapeutics Inc.|