Official Title: “Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers”

The purpose of this study is to identify subjects who are highly sensitized with antibodies.

It is difficult for these patients to find suitable kidneys.

We propose to treat such patients to decrease the antibodies in such a way, that it may become possible to safely transplant kidneys into them.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Kidney transplantation is the desired treatment of choice in subjects with end-stage kidney disease (ESRD). The average waiting time for subjects to receive a "deceased donor" kidney transplant is 3-5 years. Currently, there are about 60,000 subjects on the national waiting list, and about 13,000-14,000 kidney transplants are performed each year. Approximately, 25% of subjects on the waiting list are "highly sensitized", meaning that they have natural proteins (antibodies) that aggressively protect their bodies from the invasion of foreign proteins. These individuals often have a difficult time accepting transplanted kidneys. The purpose of this study is to identify subjects who are highly sensitized with these antibodies, and treat them in such a way, that it may become possible to transplant kidneys into them. Drugs like atorvastatin (Lipitor) may decrease the levels of these anti-bodies and increase the possibility of these subjects to receive a kidney transplant. This research study is being done because currently, there are very limited and cumbersome treatment options to address this issue, subjects who are highly sensitized with antibodies, may unfortunately wait for a very long time or may never get transplanted.

Intervention(s) in this Clinical Trial

• Drug: Atorvastatin (Lipitor)
  • 20mg every day, taken by mouth. Dose could be increased up to 60mg every day during the course of the trial if tests indicate this is needed.

Primary Measures

• This study is to identify subjects who are highly sensitized with these antibodies, and treat them in such a way, that it may become possible to transplant kidneys into them.
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• 1. Eighteen years or older, 2. On the waiting list for a kidney transplant list
• 3. On hemodialysis or peritoneal dialysis

Exclusion Criteria:

• 1. Pregnant woman
• 2. Patients who need ongoing blood products
• 3. Patients with failed organs having active rejection
• 4. Other therapies to decrease PRA
• 5. Patients listed for multi-organ transplants (other than kidney-pancreas)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Pradeep Kadambi, MD Principal Investigator The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637  

Overall Contact: Pradeep Kadambi, M.D. 773-702-1323 pkadamb@medicine.bsd.uchicago.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143741

Study ID Number: Atorvastatin 13815B

ClinicalTrials.gov Identifier: NCT00143741

Health Authority: United States: Institutional Review Board