End-Stage Kidney DiseasePhase 1NCT00143741
Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
A Phase 1 study testing Atorvastatin (Lipitor) in people with End-Stage Kidney Disease, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- Atorvastatin (Lipitor)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen years or older,
- On the waiting list for a kidney transplant list
- On hemodialysis or peritoneal dialysis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- Atorvastatin (Lipitor)
- Keywords
- Kidney Disease, Lipitor, Atorvastatin, Allosensitization
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Lipitor | Other | Not described Receives: Drug: Atorvastatin (Lipitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pradeep Kadambi, MD, Principal investigator, The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143741
- Sponsor's protocol ID
- Atorvastatin 13815B
- Status last verified
- Jan 2013
- First submitted
- 1 Sep 2005
- Last updated
- 10 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Atorvastatin (Lipitor) to Decrease Panel Reactive Antibody Titers
- ClinicalTrials.gov ID
- NCT00143741
- Acronym / sponsor ID
- Atorvastatin 13815B
- Conditions
- End-Stage Kidney Disease
- Keywords
- Kidney Disease, Lipitor, Atorvastatin, Allosensitization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipitor | Other | Drug: Atorvastatin (Lipitor) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eighteen years or older,
- On the waiting list for a kidney transplant list
- On hemodialysis or peritoneal dialysis
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Lipitor |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pradeep Kadambi, MD principal investigator
The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin (Lipitor) in people with End-Stage Kidney Disease, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.