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OpenTrials
Completed

NCT Number: NCT01430494

Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease

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.

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Key information

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Otsuka Investigational Site, Avellaneda, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. Patient-reported pain

    Time frame: every 6 months

  2. SF-12 Scores

    Time frame: every 6 months

  3. ADPKD-Impact Scale Score

    Time frame: every 6 months

  4. Cost of care

    Time frame: every 6 months

  5. EQ-5D Scores

    Time frame: Every 6 months

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

A Multi-center, Longitudinal, Observational Study of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics, and Determinants of Disease Progression

Acronym: OVERTURE

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 8, 2011
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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