Polycystic Liver Disease in Kidney Transplant - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00934791

Purpose

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.

Condition	Intervention
Kidney Transplant	Drug: Tacrolimus Drug: Sirolimus (Rapamune, Rapamycin) Drug: Mycophenolate Mofetil + Prednisone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Single Center, Open-label Randomized Prospective Trial: Effect of Sirolimus on Polycystic Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation Liver Diseases

Drug Information available for: Prednisone Sirolimus Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Everolimus CCI 779

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To examine the changes in native liver volume at year 1, 2, and 3 after kidney transplantation. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	68
Study Start Date:	February 2009
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group A Tacrolimus, Mycophenolate mofetil and prednisone	Drug: Tacrolimus Tacrolimus 6-10 mg/day (maintain trough levels of 8-10 ng/mL) Drug: Mycophenolate Mofetil + Prednisone Mycophenolate Mofetil 750 mg twice daily, Prednisone tapered to 5 mg/day by day 92
Active Comparator: Group B Sirolimus, mycophenolate mofetil and prednisone	Drug: Sirolimus (Rapamune, Rapamycin) Rapamycin 3-5 mg/day (maintain HPLC blood level 10-15 ng/mL) Other Name: Rapamune Drug: Mycophenolate Mofetil + Prednisone Mycophenolate Mofetil 750 mg twice daily, Prednisone tapered to 5 mg/day by day 92

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934791

Contacts

Contact: Qi Qian, M.D.	507-284-2511	qian.qi@mayo.edu
Contact: Aleisha Chappell	507-266-8493	chappell.aleisha@mayo.edu

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Aleisha Chappell 507-266-8493 chappell.aleisha@mayo.edu

Sponsors and Collaborators

Mayo Clinic

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Principal Investigator:	Patrick Dean, M.D.	Mayo Clinic
Principal Investigator:	QI Qian, MD	Mayo Clinic

More Information

No publications provided

Responsible Party:	Dr. Patrick Dean and Dr. Qi Qian, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00934791 History of Changes
Other Study ID Numbers:	08-004315
Study First Received:	July 6, 2009
Last Updated:	December 15, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Kidney Transplant

Additional relevant MeSH terms:

Liver Diseases
Cysts
Digestive System Diseases
Neoplasms
Pathological Conditions, Anatomical
Prednisone
Sirolimus
Mycophenolic Acid
Everolimus
Mycophenolate mofetil
Tacrolimus
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Bacterial Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012