Sirolimus for Massive Polycystic Liver (SILVER)
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ClinicalTrials.gov Identifier: NCT01680250 |
Recruitment Status
: Unknown
Verified September 2012 by Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted
: September 7, 2012
Last Update Posted
: September 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Kidney Diseases | Drug: Sirolimus | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 44 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Sirolimus
Sirolimus administration group starting dose: 2mg/day target trough level: 4-10 ng/dL
|
Drug: Sirolimus
Sirolimus administration for 12 months followed by conventional therapy alone for additional 12 months
Other Name: Rapamune
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- Total liver volume [ Time Frame: 12 months ]Change in total liver volume
- Total liver volume [ Time Frame: 24 months ]Change in total liver volume
- Total kidney volume [ Time Frame: 12 month ]Change in total kidney volume
- Estimated glomerular filtration rate [ Time Frame: 12 month ]Change in estimated glomerular filtration rate
- Urinary biomarker [ Time Frame: 12 month ]Urinary biomarker level
- Total kidney volume [ Time Frame: 24 month ]Change in total kidney volume
- Estimated glomerular filtration rate [ Time Frame: 24 month ]Change in estimated glomerular filtration rate
- Urinary biomarker [ Time Frame: 24 month ]Urinary biomarker level
- Abdominal pain [ Time Frame: 12month ]Abdominal pain quantified by Visual Analog Scale
- Abdominal pain [ Time Frame: 24 month ]Abdominal pain quantified by Visual Analog Scale
- Infection [ Time Frame: 24 month ]Incidence of infection event during study time
- Hospitalization [ Time Frame: 24 month ]Incidence of hospitalization due to adverse events during study time
- Drop out [ Time Frame: 24 month ]Incidence of discontinuation of study drug due to serious adverse events during study time

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01680250
Contact: Curie Ahn, MD, PhD | 82-2-2072-2222 | curie@snu.ac.kr |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Curie Ahn, MD, PhD 82-2-2072-2222 curie@snu.ac.kr |
Principal Investigator: | Curie Ahn, MD, PhD | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01680250 History of Changes |
Other Study ID Numbers: |
SILVER |
First Posted: | September 7, 2012 Key Record Dates |
Last Update Posted: | September 7, 2012 |
Last Verified: | September 2012 |
Keywords provided by Seoul National University Hospital:
Total liver volume Liver cyst |
Additional relevant MeSH terms:
Kidney Diseases Polycystic Kidney Diseases Urologic Diseases Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Sirolimus Everolimus |
Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |