Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
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Purpose
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers |
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | May 2005 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Lipitor |
Drug: Atorvastatin (Lipitor)
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.
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Illinois | |
| The University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| Principal Investigator: | Pradeep Kadambi, MD | The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637 |
More Information
No publications provided
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00143741 History of Changes |
| Other Study ID Numbers: | Atorvastatin 13815B |
| Study First Received: | September 1, 2005 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Kidney Disease, Lipitor, Atorvastatin, Allosensitization |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Antibodies Atorvastatin Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013