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.

Condition	Intervention	Phase
End-Stage Kidney Disease	Drug: Atorvastatin (Lipitor)	Phase I

Further Study Details: 

Primary Outcomes: 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.
Secondary Outcomes: Monitor serum Lipid levels
Expected Total Enrollment:  10

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.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00143741

Pradeep Kadambi, M.D.      773-702-1323    pkadamb@medicine.bsd.uchicago.edu
Sara Rosenkoetter, RN, BSN      773-834-9796    srosenko@medicine.bsd.uchicago.edu

Illinois
      The University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  Atorvastatin 13815B
Last Updated:  September 1, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00143741
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06