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Study of Weekly RG-012 Injections in Patients With Alport Syndrome (HERA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Regulus Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02855268
First received: July 28, 2016
Last updated: November 7, 2016
Last verified: November 2016
  Purpose
This will be a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study conducted in subjects with Alport syndrome at multiple investigative centers.

Condition Intervention Phase
Alport Syndrome Drug: RG-012 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Dose Selection, and Preliminary Efficacy of Weekly RG 012 Injections in Patients With Alport Syndrome

Resource links provided by NLM:


Further study details as provided by Regulus Therapeutics Inc.:

Primary Outcome Measures:
  • Safety and tolerability assessed by the number of subjects with Adverse Events [ Time Frame: 24 Weeks ]
    Assessed by variables such as AEs, laboratory parameters, vital signs, ECGs, and injection site reactions


Estimated Enrollment: 30
Study Start Date: August 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
1 mL, weekly, 24 weeks
Drug: Placebo
2 µg/mL riboflavin in 0.9% sodium chloride
Experimental: Dose A
110 mg RG-012 in 1 mL, weekly, 24 weeks
Drug: RG-012
RG456070 in 0.3% sodium chloride
Other Name: Active
Experimental: Dose B
220 mg RG-012 in 1 mL, weekly 24 weeks
Drug: RG-012
RG456070 in 0.3% sodium chloride
Other Name: Active

Detailed Description:

This will be a randomized, double-blind, placebo-controlled, multi-center, Phase 2 study conducted in subjects with Alport syndrome at multiple investigative centers.To meet the GFR enrollment criteria, subjects must have an eGFR of 45 to 90 ml/min/1.73 m2 at the first screening visit and demonstrate a decline in eGFR during the screening period. Subjects may screen for enrollment directly in this study or after participation in the RG012-01 ATHENA Natural History Study.

For subjects participating in the ATHENA Study, genotype, demographics, prior/concomitant medications, medical history, and family history data from that study may be used to satisfy entry criteria in the current study. Data obtained in the ATHENA Study for clinical laboratory tests (other than eGFR) may be used as screening data for the present study if obtained within 4 weeks prior to baseline. Physical examination results from the ATHENA study may be used as screening data for the present study if obtained within 12 weeks prior to baseline.

Active Treatment Period - Eligible subjects will be randomized in a 1:1:1 ratio to receive weekly subcutaneous (SC) injections of RG-012 110 mg, RG-012 220 mg, or placebo for 24 weeks.

Subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) will be required to maintain these agents at a stable dose and regimen for the duration of the active treatment period. All other concomitant medications should also be maintained at a stable dose and regimen during the study.

Follow-up Period - Subjects completing 24 weeks of treatment will be eligible to screen for enrollment in an extension study in which all subjects receive active treatment. Subjects who do not enter the extension will have a safety follow-up home visit 4 weeks (Week 28) after the end of the active treatment period and a safety follow-up clinic visit 12 weeks (Week 36) after the end of the active treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects aged 18 to 65 years (inclusive)
  2. Confirmed diagnosis of Alport syndrome (clinical, histopathologic, and/or genetic diagnosis)
  3. eGFR criteria must be met
  4. Proteinuria ≥500 mg protein/g creatinine at initial screening and baseline visits
  5. On a stable dosing regimen of an ACE inhibitor and/or ARB for ≥30 days prior to screening (unless unable to tolerate either an ACE inhibitor or an ARB)

Exclusion Criteria:

  1. Causes of chronic kidney disease aside from Alport syndrome (including, but not limited to, diabetic nephropathy, hypertensive nephropathy, lupus, IgA nephropathy)
  2. ESRD as evidenced by ongoing dialysis therapy or history of renal transplantation
  3. Any other condition or circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety and well-being
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02855268

Locations
United States, California
San Diego, California, United States, 92120
United States, New York
New York, New York, United States, 10032
Sponsors and Collaborators
Regulus Therapeutics Inc.
  More Information

Responsible Party: Regulus Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02855268     History of Changes
Other Study ID Numbers: RG012-03
Study First Received: July 28, 2016
Last Updated: November 7, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Regulus Therapeutics Inc.:
Kidney disease, nephritis

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

ClinicalTrials.gov processed this record on July 27, 2017