Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers

Phase 1

Completed

• Conditions: End-Stage Kidney Disease
• Interventions: Drug: Atorvastatin (Lipitor)

• Registration Number: NCT00143741
• Lead Sponsor: University of Chicago

Brief 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.

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2010-12
• Study Completion: 2011-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-09
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipitor	Atorvastatin (Lipitor)	-

Primary Outcome Measures

Name	Time	Method
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.	6 months

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States