Back to resultsEffect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lipitor
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Statin
Eligibility Criteria
Inclusion Criteria:
- All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
- Accepting to participate in the study
Exclusion Criteria:
- Refusing to participate in the study
Sites / Locations
- Shahid Mohammadi hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lipitor
Arm Description
atorvastatin 20mg daily
Outcomes
Primary Outcome Measures
Serum IgG, IgA and IgM level
Secondary Outcome Measures
Drug side effects
Full Information
NCT ID
NCT01305317
First Posted
February 25, 2011
Last Updated
February 28, 2011
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01305317
Brief Title
Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
Official Title
Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas
Detailed Description
This study is a randomized controlled trial of statins effect on serum IgG, IgA and IgM level on chronic hemodialysis patients in Bandarabbas. The study is carried out in Hormozgan, Iran. Seventy four patient were randomized either to receive atorvastatin in addition of usual treatment or not. The primary outcomes were serum IgG,IgA and IgM level. The secondary outcome was drug side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Statin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lipitor
Arm Type
Experimental
Arm Description
atorvastatin 20mg daily
Intervention Type
Drug
Intervention Name(s)
Lipitor
Other Intervention Name(s)
atorvastatin, statins
Intervention Description
Atorvastatin 20mg daily for 6 months
Primary Outcome Measure Information:
Title
Serum IgG, IgA and IgM level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drug side effects
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
Accepting to participate in the study
Exclusion Criteria:
Refusing to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamidreza Mahboobi
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Mohammadi hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
79176
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
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