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| Sponsor: | University of Chicago |
|---|---|
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00143741 |
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 I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers |
| Estimated Enrollment: | 10 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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:
Exclusion Criteria:
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
| Responsible Party: | Pradeep Kadambi, MD, 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 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Kidney Disease, Lipitor, Atorvastatin, Allosensitization |
|
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 |