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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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End-Stage Kidney Disease

Intervention / Treatment
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* Drug: Atorvastatin (Lipitor)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lipitor<br> | Drug: Atorvastatin (Lipitor)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Disease, Lipitor, Atorvastatin, Allosensitization