Polycystic Liver Disease in Kidney Transplant

NCT00934791 | Terminated Results

• 1 other identifier: 08-004315
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Polycystic Liver Disease

Keywords

Kidney Transplant; Autosomal dominant polycystic kidney disease; Polycystic liver disease

Outcome Measures

Primary Outcomes (1)

• Liver Volume at 2 Years After Kidney Transplantation

  Liver volume at 2 years will be compared between the sirolimus and control (tacrolimus) groups using analysis of covariance (ANCOVA).

  2 years

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Tacrolimus, mycophenolate mofetil, and prednisone

Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Drug: Prednisone

Sirolimus Group

ACTIVE COMPARATOR

Sirolimus, mycophenolate mofetil, and prednisone

Drug: Sirolimus; Drug: Mycophenolate Mofetil; Drug: Prednisone

Interventions

Tacrolimus DRUG

Tacrolimus 6-10 mg/day (maintain trough levels of 8-10 ng/mL)

Also known as: Prograf

Control Group

Sirolimus DRUG

Sirolimus 3-5 mg/day (maintain high-performance liquid chromatography (HPLC) blood level 10-15 ng/mL)

Also known as: Rapamune, Rapamycin

Sirolimus Group

Mycophenolate Mofetil DRUG

Mycophenolate Mofetil 750 mg twice daily

Also known as: Cellcept

Control Group; Sirolimus Group

Prednisone DRUG

Prednisone tapered to 5 mg/day by day 92

Also known as: Deltasone

Control Group; Sirolimus Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Polycystic liver disease; Polycystic Kidney, Autosomal Dominant

Interventions

Tacrolimus; Sirolimus; Mycophenolic Acid; Prednisone

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This study was terminated due to inadequate enrollment, no data was collected on the participant.

Results Point of Contact

• Title: Dr. Patrick G. Dean
• Organization: Mayo Clinic

dean.patrick2@mayo.edu

507-266-6953

Study Officials

• Patrick Dean, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• QI Qian, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

US (1)