NCT00143741

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 10, 2013

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

September 1, 2005

Last Update Submit

January 9, 2013

Conditions

End-Stage Kidney Disease

Keywords

Kidney Disease, Lipitor, Atorvastatin, Allosensitization

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lipitor

OTHER
Drug: Atorvastatin (Lipitor)

Interventions

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.

Lipitor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eighteen years or older,
  • On the waiting list for a kidney transplant list
  • On hemodialysis or peritoneal dialysis

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicKidney Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Pradeep Kadambi, MD

    The University of Chicago, 5841 South Maryland Ave., MC 5100 Chicago, IL 60637

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

January 10, 2013

Record last verified: 2013-01

Locations

US(1)