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Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)

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Otsuka

Status

Completed

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Study type

Observational

Funder types

Industry

Identifiers

NCT01430494
156-10-291

Details and patient eligibility

About

To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes). Association with total kidney volume changes and other measures of disease progression will be determined in order to identify a population at increased risk for disease progression. The economic and quality life impact of ADPKD will be assessed. Subjects who terminated participation early from clinical trials with tolvaptan may also be followed.

Enrollment

3,409 patients

Sex

All

Ages

12 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • existing diagnosis of ADPKD by modified-Ravine criteria
  • Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI

Exclusion criteria

  • Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume

Trial design

3,409 participants in 1 patient group

No treatment

Trial contacts and locations

266

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Data sourced from clinicaltrials.gov

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