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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 February 2015 |
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Main ID: |
NCT01680250 |
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Date of registration:
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30/08/2012 |
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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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Sirolimus for Massive Polycystic Liver
SILVER |
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Scientific title:
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An Open-label, Prospective Clinical Trial to Evaluate the Effectiveness and Safety of Sirolimus to Reduce Cyst Growth in ADPKD Patients With Massive Polycystic Liver |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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44 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01680250 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Curie Ahn, 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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Seoul National University Hospital |
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Name:
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Curie Ahn, MD, PhD |
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Address:
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Telephone:
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82-2-2072-2222 |
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Email:
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curie@snu.ac.kr |
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Affiliation:
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Name:
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Curie Ahn, MD, PhD |
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Address:
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Telephone:
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82-2-2072-2222 |
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Email:
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curie@snu.ac.kr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 - 65
- Patients diagnosed as ADPKD based upon the unified criteria for ultrasonographic
diagnosis of ADPKD
- Polycystic liver with total liver volume > 2500 mL or symptomatic polycystic liver
- Estimated glomerular filtration rate (IDMS-traceable MDRD equation) >= 30
mL/min/1.73m2
Exclusion Criteria:
- Concomitant systemic renal parenchymal or urinary tract disease (random urine
albumin-to-creatinine ratio > 500 mg/g)
- WBC < 4,000/uL, platelet < 100,000/uL, or hemoglobin < 10.0 g/dL
- Diabetes mellitus, cancer, or psychiatric disorder
- Increased liver enzymes (2-fold above normal value)
- Hypercholesterolemia (fasting cholesterol > 200mg/dL) or hypertriglyceridemia (>150
mg/dL) not controlled by lipid lowering therapy
- Infection with hepatitis B, C, HIV
- Any condition that could prevent full comprehension of the purpose and risks of the
study
- Pregnant or lactating women or fertile women without effective contraception
- History of intervention, such as cyst aspiration or embolization in past 1 year
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Polycystic Kidney Diseases
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Intervention(s)
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Drug: Sirolimus
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Primary Outcome(s)
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Total liver volume
[Time Frame: 12 months]
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Secondary Outcome(s)
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Total kidney volume
[Time Frame: 12 month]
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Estimated glomerular filtration rate
[Time Frame: 24 month]
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Total kidney volume
[Time Frame: 24 month]
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Estimated glomerular filtration rate
[Time Frame: 12 month]
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Urinary biomarker
[Time Frame: 12 month]
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Total liver volume
[Time Frame: 24 months]
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Urinary biomarker
[Time Frame: 24 month]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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