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Study of RG-012 in Male Subjects With Alport Syndrome (HERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02855268
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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 : November 2018
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

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


Contacts
Contact: Mark Deeg, M.D. 858-202-6343 mdeeg@regulusrx.com
Contact: Lisa Ann Melia, M.A. 858-202-6323 lmelia@regulusrx.com

Locations
United States, California
eStudySite Recruiting
La Mesa, California, United States, 91942
Contact: Melanie Devera    619-567-1550    mdevera@estudysite.com   
Principal Investigator: J. Scott Overcash, M.D.         
Academic Medical Research Institute Recruiting
Los Angeles, California, United States, 90022
Contact: Emad Bayoumi    323-725-0051    ebayoumi@amrionline.net   
Principal Investigator: Mohamed El-Shahawy, M.D.         
United States, Florida
Eminence Medical & Clinical Research Recruiting
Tampa, Florida, United States, 33604
Contact: Roniel Perez    813-443-8487    roniel@eminencemedicalresearch.com   
Principal Investigator: Cecilio Hernandez, M.D.         
United States, Missouri
Clinical Research Consultants, LLC Recruiting
Kansas City, Missouri, United States, 64111
Principal Investigator: Ahmed Awad, M.D.         
United States, Ohio
The Ohio State University Nephrology Clinical Trials Unit Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Isabelle Ayoub, M.D.         
United States, Texas
Houston Nephrology Research Recruiting
Cypress, Texas, United States, 77429
Principal Investigator: Rupi K Chatha, M.D.         
Nephrotex Research Group Recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Sumit Kumar, M.D.         
United States, Utah
Utah Kidney Research Institute Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Tiffany Herndon    801-747-9186    ukrinephrology@gmail.com   
Principal Investigator: Sanjiv Anand, M.D.         
United States, Virginia
Washington Nephrology Associates Recruiting
Alexandria, Virginia, United States, 22304
Contact: Ehtisham Akhter    410-952-5307    ehtishamakhter@yahoo.com   
Principal Investigator: Bala Subramanian, M.D.         
United States, Wisconsin
Allegiance Research Specialists, LLC Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Nancy Niemann    414-727-8131    niemann@arsmke.com   
Principal Investigator: Andrew Kim, M.D.         
Sponsors and Collaborators
Regulus Therapeutics Inc.
Investigators
Study Director: Mark Deeg, M.D. Regulus Therapeutics Inc.
More Information

Additional Information:
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 22, 2017
Last Verified: December 2017
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