Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease (OVERTURE)
This study is ongoing, but not recruiting participants.
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01430494
First received: July 29, 2011
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Autosomal Dominant Polycystic Kidney Disease (ADPKD) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Primary Outcome Measures:
- Correlation of change in total kidney volume with ADPKD-related outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient-reported pain [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- SF-12 Scores [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- ADPKD-Impact Scale Score [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Cost of care [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- EQ-5D Scores [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| No treatment |
Eligibility| Ages Eligible for Study: | 12 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects will be identified by participating clinics (primarily nephrology clinics) treating patients with ADPKD.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430494
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| United States, Alabama | |
| Otsuka Investigational Site | |
| Mobile, Alabama, United States, 36617 | |
| United States, Arizona | |
| Otsuka Investigational Site 1 | |
| Peoria, Arizona, United States, 85381 | |
| Otsuka Investigational Site 2 | |
| Peoria, Arizona, United States, 85381 | |
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| Phoenix, Arizona, United States, 85012 | |
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| Tempe, Arizona, United States, 85284 | |
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| Azusa, California, United States, 91702 | |
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| Bakersfield, California, United States, 93308 | |
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| Los Angeles, California, United States, 90022 | |
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| Los Angeles, California, United States, 90025 | |
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| Los Angeles, California, United States, 90033 | |
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| Ontario, California, United States, 91762 | |
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| Whittier, California, United States, 90603 | |
| United States, Colorado | |
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| Arvada, Colorado, United States, 80002 | |
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| Aurora, Colorado, United States, 80045 | |
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| Denver, Colorado, United States, 80210 | |
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| New Haven, Connecticut, United States, 06510 | |
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| Washington, District of Columbia, United States, 20037 | |
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| Jacksonville, Florida, United States, 32216 | |
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| Fairfax, Virginia, United States, 22030 | |
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| Madison, Wisconsin, United States, 53713 | |
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| Avellaneda, Buenos Aires, Argentina, 1872 | |
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| Pergamino, Buenos Aires, Argentina, 2700 | |
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| Sante Fe, Argentina, 3000 | |
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| Liverpool, New South Wales, Australia, 2170 | |
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| Salvador, BA, Brazil, 40110-160 | |
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| São Luíz, MA, Brazil, 65070-905 | |
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| Belo Horizonte, MG, Brazil, 30180-060 | |
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| Juiz De Fora, MG, Brazil, 36036-330 | |
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| Curitiba, PR, Brazil, 80440-020 | |
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| São Paulo, Brazil, 04039-000 | |
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| Ceske Budejovice, Czech Republic, 370 01 | |
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| Drammen, Norway, 3004 | |
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| Edinburgh, Scotland, United Kingdom, EH16 4SA | |
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| Belfast, United Kingdom, BT9 7ABB | |
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| Cambridge, United Kingdom, CB2 0QQ | |
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| Inverness, United Kingdom, IV2 3UJ | |
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| Leicester, United Kingdom, LE5 4PW | |
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| London, United Kingdom, NW3 2PF | |
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| London, United Kingdom, WC1N 3JH | |
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| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
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| Oxford, United Kingdom, OX3 7LJ | |
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| Salford, United Kingdom, M6 8HD | |
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| Sheffield, United Kingdom, S5 7AU | |
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| Shirley, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
| Study Director: | Frank Czerwiec, MD, PhD | Otsuka Pharmaceutical Development & Commercialization, Inc. |
More Information
No publications provided
| Responsible Party: | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| ClinicalTrials.gov Identifier: | NCT01430494 History of Changes |
| Other Study ID Numbers: | 156-10-291 |
| Study First Received: | July 29, 2011 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Disease Progression |
Urologic Diseases Kidney Diseases, Cystic Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013