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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
Sponsor:
Information provided by (Responsible Party):
Regulus Therapeutics Inc.

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study of the safety and efficacy of RG-012 administered to male subjects with Alport syndrome.

Condition or disease Intervention/treatment Phase
Alport Syndrome Drug: RG-012 Drug: Placebo Phase 2

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RG-012
1.5 mg/kg subcutaneous injection
Drug: RG-012
RG-012 in 0.3% sodium chloride
Other Name: Active

Placebo Comparator: Placebo Drug: Placebo
matching placebo for injection




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male, age 18 to 60 years (inclusive)
  2. Confirmed diagnosis of Alport syndrome (clinical and genetic)
  3. eGFR between 40 and 90 mL/min/1.73m2
  4. Proteinuria ≥ 300 mg protein/g creatinine at screening
  5. For subjects taking an ACE inhibitor and/or ARB, the dosing regimen should be stable for at least 30 days prior to screening

Exclusion Criteria:

  1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus, or IgA nephropathy)
  2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or a history of renal transplantation
  3. Weight > 110 kg (242.5 pounds)
  4. Any other condition that may pose a risk to the subject's safety and well-being

Information from the National Library of Medicine

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
Sponsors and Collaborators
Regulus Therapeutics Inc.
Investigators
Study Director: Mark Deeg, M.D. Regulus Therapeutics Inc.

Responsible Party: Regulus Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02855268     History of Changes
Other Study ID Numbers: RG012-03
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regulus Therapeutics Inc.:
Kidney disease
Nephritis
Hereditary nephritis
Hereditary kidney disease

Additional relevant MeSH terms:
Syndrome
Nephritis, Hereditary
Disease
Pathologic Processes
Urogenital Abnormalities
Nephritis
Kidney Diseases
Urologic Diseases
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases