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Main
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Note: This record shows only the 20 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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14 January 2013 |
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Main ID: |
NCT00934791 |
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Date of registration:
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06/07/2009 |
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Primary sponsor: |
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Public title:
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Polycystic Liver Disease in Kidney Transplant
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Scientific title:
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Single Center, Open-label Randomized Prospective Trial: Effect of Sirolimus on Polycystic Liver Disease |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00934791 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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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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Patrick Dean, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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QI Qian, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adults (> 18 years old) with stage IV or V chronic kidney due to ADPKD
- Primary kidney transplant
- Living or deceased donor kidney transplant
- Estimate total liver volume of 2.5 to 7.5 L
Exclusion Criteria:
- Pediatric patients (< 18 years of age)
- Patients with BMI > 40
- Multi-organ transplant (kidney-liver, etc.)
- ABO-incompatible or positive cross-match recipients
- Patients with severe hyperlipidemia (serum cholesterol > 350 mg/dl or serum
triglycerides > 500 mg/dl)
- Patients with leukopenia (WBC < 3000 10/ml)
- Patients unwilling to return to the transplant center for late follow-up visits
- Patients who are currently pregnant or breast-feeding or who expect to be pregnant
during the study period
- Female patients of child bearing potential and men with sexual partners of child
bearing potential who do not agree to use a medically accepted method of
contraception during the study period
- Patients who are not eligible for Thymoglobulin induction
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Transplant
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Intervention(s)
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Drug: Mycophenolate Mofetil + Prednisone
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Drug: Sirolimus (Rapamune, Rapamycin)
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Drug: Tacrolimus
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Primary Outcome(s)
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To examine the changes in native liver volume at year 1, 2, and 3 after kidney transplantation.
[Time Frame: 3 years]
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Secondary Outcome(s)
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To examine the changes in native kidney volumes and to examine additional safety data (serum lipid profile and blood counts) in ADPKD patients population.
[Time Frame: 3 years]
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Secondary ID(s)
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08-004315
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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