Polycystic Liver Disease in Kidney Transplant

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 immunosuppressive drugs that will be compared for this study. Both drugs have been commonly prescribed to prevent rejection.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Sirolimus; Tacrolimus

Criteria

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

• 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 Criteria:

• 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