Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
Information source: University of Chicago
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End-Stage Kidney Disease
Intervention: Atorvastatin (Lipitor) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Pradeep Kadambi, MD, Principal Investigator, Affiliation: The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637
Overall contact:
Pradeep Kadambi, M.D., Phone: 773-702-1323, Email: pkadamb@medicine.bsd.uchicago.edu
Summary
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.
Clinical Details
Official title: Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
Study design: Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Pradeep Kadambi, M.D., Phone: 773-702-1323, Email: pkadamb@medicine.bsd.uchicago.edu
The University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Kathy Reilly, RN, BSN, Phone: 773-702-1526, Email: kreilly@medicine.bsd.uchicago.edu
Pradeep Kadambi, MD, Principal Investigator
Additional Information
Starting date: May 2005
Ending date: June 2010
Last updated: July 29, 2009
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