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Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Chicago.   Recruitment status was  Active, not recruiting

First Received on September 1, 2005.   Last Updated on January 28, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    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
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143741

Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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: 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

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 February 09, 2012