Status:
TERMINATED
Polycystic Liver Disease in Kidney Transplant
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Polycystic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if one kind of immunosuppressive drug has better effects for the patient's polycystic liver disease than another type. Tacrolimus and Sirolimus are the two immunosu...
Detailed Description
Autosomal dominant polycystic kidney disease (ADPKD) is a life-threatening monogenic disease with a prevalence of 1 in 400-1000 livebirths. ADPKD is caused by mutations to polycystic kidney disease 1 ...
Eligibility Criteria
Inclusion
- 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
- In addition, at the discretion of the principal investigator(s), certain subjects with numerous liver cysts but with liver volume \< 2.5 liters may be enrolled.
Exclusion
- Pediatric patients (\< 18 years of age)
- Patients with Body Mass Index (BMI) greater than or equal to 40 kg/m\^2
- Multi-organ transplant (kidney-liver, etc.)
- When people who have one blood type receive blood from someone with a different blood type, it may cause their immune system to react. This is called (ABO) incompatibility. 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00934791
Start Date
February 1 2009
End Date
December 1 2012
Last Update
March 8 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905