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ATHENA: Natural History of Disease Study in Alport Syndrome Patients
ATHENA: Natural History of Disease Study in Alport Syndrome Patients

NCT02136862

CompletedN/A

Sponsor: Genzyme, a Sanofi Company

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

Countries: United States, Australia, Canada, France, Germany, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (15)
  • San Diego, California, United States
  • Chicago, Illinois, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Plano, Texas, United States
  • Salt Lake City, Utah, United States
  • New Lambton, New South Wales, Australia
  • Parkville, Victoria, Australia
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Paris, France
  • Göttingen, Germany
  • London, United Kingdom