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Adult Trials: 18+ Years
- 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
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Sirolimus for Massive Polycystic Liver | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | The purpose of this study is to evaluate the effectiveness and safety of Sirolimus in reducing liver volume in autosomal dominant polycystic kidney disease. | |||
| Detailed Description | Autosomal dominant polycystic kidney disease (ADPKD) is one of the most common causes of end stage renal disease (ESRD), affecting an estimated 0.2% of population. Of ADPKD patients, 58% in 15-24 year, 85% in 25-34 year, and 94% in 35-46 year olds suffer from polycystic liver in addition to polycystic kidneys. Several anti-proliferative drugs have been used in clinical trials to stop cyst growth both in liver and kidneys. Among them, octreotide and sirolimus have been shown to be one of the most promising drugs to reduce cyst volume. Sirolimus already has been used as one of the most potential oral immunosuppressants. Moreover, the serum trough level is quite easy to measure. Sirolimus is the mTOR inhibitor that has been proven to be effective in reducing cyst growth both in animal models. However, its efficacy and safety is not well proven in previous studies. This is a open-label, prospective study to evaluate the effectiveness and safety of Sirolimus to reduce cyst growth in ADPKD patients with massive polycystic liver. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 Phase 3 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Polycystic Kidney Diseases | |||
| Intervention ICMJE | Drug: Sirolimus
Sirolimus administration for 12 months followed by conventional therapy alone for additional 12 months Other Name: Rapamune | |||
| Study Arms ICMJE | Experimental: Sirolimus
Sirolimus administration group starting dose: 2mg/day target trough level: 4-10 ng/dL Intervention: Drug: Sirolimus | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Unknown status | |||
| Estimated Enrollment ICMJE | 44 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Estimated Study Completion Date ICMJE | August 2015 | |||
| Estimated Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Korea, Republic of | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01680250 | |||
| Other Study ID Numbers ICMJE | SILVER | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Seoul National University Hospital | |||
| Study Sponsor ICMJE | Seoul National University Hospital | |||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Seoul National University Hospital | |||
| Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||