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OpenTrials
Completed

NCT Number: NCT00143741

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

atorvastatin (Lipitor)

Drug

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Sep 2, 2005
Registry last updated
Jan 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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