Amendments and Updates on ATHENA Study

Amendments and Updates on ATHENA Study

Regulus Therapeutics recently announced amendments and updates for the worldwide ATHENA study on Alport Syndrome.


New Eligibility Criteria
Regulus Therapeutics is continuing to enroll patients in the ATHENA Natural History Study and has recently amended the eligibility criteria as follows:

  • The age range of patients is now 12 and 65 years (changed from 16 years or older).
  • The GFR (Glomerular Filtration Rate) range increased to 45 to 90 mL/min (changed from 30 to 75 mL/min).
  • Estimated GFR (eGFR) will be the method for assessing GFR going forward. Measured GFR (mGFR) using the iohexol method will no longer be required for new patients coming into screening; however, patients already enrolled will be asked to complete at least three mGFR’s using the iohexol method before switching to the eGFR method.

You may be contacted if you were not eligible under the previous criteria but now meet the current requirements.


New Clinical Sites
Regulus is in the process of adding new clinical sites to the ATHENA study throughout the US, Europe, and Asia-Pacific. New study sites have recently been announced in Plano, TX, Atlanta, GA, Washington, DC, and Barcelona, Spain. These sites are now actively recruiting patients.

As additional sites are approved they will be added to the study website and clinicaltrials.gov and announced via the ASF newsletter and social media.

If you are interested in finding the site closest to you, please check the study website.


Phase 1 Study Completed
Regulus has completed the Phase 1 Study to test the safety of their anti-microRNA21 therapy (RG-012) for the treatment of Alport syndrome in healthy volunteers. RG-012 was well-tolerated with no serious adverse events or discontinuations reported by study participants.


Phase 2 Study Coming Soon
The Phase 2 program is targeted to begin mid-2016. Patients participating in the ATHENA Natural History Study may be offered the opportunity to roll into the Phase 2 study if they meet the eligibility criteria for this phase of the trial.

 

A simple guide to understanding clinical trial phases is provided on the ASF blog for those unfamiliar with the process.

If you have any questions please contact the study coordinator.



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