ATHENA: Natural History of Disease Study in Alport Syndrome Patients

Completed

Conditions studied: Alport Syndrome Patients With eGFR Between 45-90 ml/Min/1.73 m2

In brief

There is limited published clinical data about the natural history of renal disease in Alport syndrome. The RG012-01 study will collect data to characterize the progression of renal dysfunction in Alport syndrome patients. Patients with a confirmed diagnosis of Alport syndrome who have qualifying GFR will be considered for enrollment. The sequential sampling of subjects' urine and/or blood will allow an assessment of the rate of change of established clinical endpoints, such as GFR and/or the rate of change of other renal biomarkers (proteinuria and β-2 microglobulin) in subjects whose renal function is steadily declining. The identification of surrogate markers that track the decline of renal function and could correlate with time to end-stage renal disease (ESRD) is a key goal of the natural history study.

Key facts

Study ID

NCT02136862

Run by

Genzyme, a Sanofi Company

People needed

165

Starts

2014-09-04

Expected to finish

2017-12-18

Last updated by the study team

2019-07-02

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and comply with the requirements of the study and willing and able to provide written informed consent; pediatric subjects must be able to provide assent;
• Age 12-65 years of age;
• Confirmed diagnosis of Alport syndrome (clinical, histopathologic and/or genetic diagnosis of Alport syndrome);
• eGFR 45-90 ml/min/1.73 m2, within 30 days of enrollment.

You may not qualify if…

• Use of investigational drugs at the time of enrollment, or within 30 days, or 5 half-lives of enrollment, whichever is longer;
• Ongoing chronic hemodialysis therapy and/or renal transplant recipient.

Where it is running

• Study site — San Diego, California, United States
• Study site — Chicago, Illinois, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Plano, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — New Lambton, New South Wales, Australia
• Study site — Parkville, Victoria, Australia
• Study site — Vancouver, British Columbia, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Paris, France
• Study site — Göttingen, Germany
• Study site — London, United Kingdom

Full record on ClinicalTrials.gov

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