Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305317
• Other study ID #: statins and Immunoglobulins
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: February 28, 2011
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: January 2006
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2010
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Lipitor
Atorvastatin 20mg daily for 6 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Mohammadi hospital	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IgG, IgA and IgM level		6 months	No
Secondary	Drug side effects		6 months	Yes