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COMPLETED CLINICAL TRIALS

ATHENA Natural History Study

Conducted by Regulus Therapeutics

STATUS

The study results are being used in research. Recruitment for the study ended in June 2017.

SUMMARY

The ATHENA trial was a natural history study to collect data to characterize or measure the progress of kidney disease in Alport syndrome patients over the course of 6 to 24 months. No investigational treatment for Alport syndrome was provided in this study and participants were able to remain on any medications prescribed by their physicians.

SUMMARY

The CARDINAL Study is investigating bardoxolone methyl given as a once-daily oral medication that promotes normal mitochondrial function and potentially reduces kidney inflammation. Reata Pharmaceuticals has already completed prior studies of the drug for patients with chronic kidney disease (CKD) caused by type 2 diabetes, with favorable results. Currently the effectiveness of bardoxolone methyl is being tested on patients with Alport syndrome.

The Phase 2 CARDINAL Study, a two-year commitment by patients, is investigating how the drug affects the chronic inflammation and decline in kidney function that are key features of Alport syndrome. The Phase 2 portion of the study enrolled 30 patients who received the active drug.

The Phase 3 CARDINAL Study continues to evaluate the drug bardoxolone methyl in Alport syndrome. This international study enrolled 150+ patients, who are receiving the active drug or placebo. Participants receive compensation and/or reimbursement for study-related time and travel, including flight or lodging costs.

Multiple Ascending Dose Study

Conducted by Regulus Therapeutics

STATUS

The Multiple Ascending Dose study was completed in mid-2017.

SUMMARY

In response to feedback from European regulatory agencies requesting additional information on how the drug RG-012 works and interacts with the body after repeated injections, Regulus Therapeutics initiated a Phase 1 multiple ascending dose study in healthy volunteers.

RG-012 is an investigational anti-microRNA 21 drug administered weekly through injection using a small injection needle similar to those used to administer insulin to people with diabetes.

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