CompletedNot Applicable

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

United States3,409 participantsStarted 2011-06-01

Plain-language summary

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.

Who can participate

Age range12 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Correlation of change in total kidney volume with ADPKD-related outcomes

Timeframe: 1 year

Trial details

NCT IDNCT01430494

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-10-01

View on ClinicalTrials.gov More Autosomal Dominant Polycystic Kidney Disease (ADPKD) trials