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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00920309 |
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Date of registration:
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12/06/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Rapamycin as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD): The Role of Biomarkers in Predicting a Response to Therapy
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Scientific title:
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Rapamycin as Treatment for ADPKD: The Role of Biomarkers in Predicting a Response to Therapy |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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21 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00920309 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Neera K Dahl, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Yale University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult ADPKD patients aged 18-70
- combined kidney volume >1200 ml
- estimated creatinine clearance >60 ml/min
- absence of implanted ferromagnetic objects
Exclusion Criteria:
- Age >70
- uncontrolled hyperlipidemia
- Proteinuria >500 mg/day
- unstable cerebral aneurysm
- active coronary artery disease
- diagnosis of another systemic condition affecting kidney function (ie: diabetes,
hepatitis B or C, HIV)
- diagnosis of cancer other than skin cancer
- pregnancy or lactation
- presence of implanted ferromagnetic objects
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autosomal Dominant Polycystic Kidney Disease
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Intervention(s)
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Other: Standard of Care-Placebo
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Drug: Rapamycin
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Primary Outcome(s)
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Total Kidney Volume (mL)
[Time Frame: 2 years]
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Secondary Outcome(s)
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Glomerular Filtration Rate (Kidney Function)
[Time Frame: 2 years]
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Secondary ID(s)
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HIC#0903004934
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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