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

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01305317
First received: February 25, 2011
Last updated: February 28, 2011
Last verified: January 2006
  Purpose

This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas


Condition Intervention
Chronic Kidney Disease
Drug: Lipitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • Serum IgG, IgA and IgM level [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lipitor
atorvastatin 20mg daily
Drug: Lipitor
Atorvastatin 20mg daily for 6 months
Other Name: atorvastatin, statins

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305317

Locations
Iran, Islamic Republic of
Shahid Mohammadi hospital
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 79176
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Principal Investigator: Hamidreza Mahboobi Hormozgan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Hamidreza Mahboobi, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01305317     History of Changes
Other Study ID Numbers: statins and Immunoglobulins
Study First Received: February 25, 2011
Last Updated: February 28, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Statin

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014