NCT01305317

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
Last Updated

March 1, 2011

Status Verified

January 1, 2006

Enrollment Period

1 year

First QC Date

February 25, 2011

Last Update Submit

February 28, 2011

Conditions

Chronic Kidney Disease

Keywords

Statin

Outcome Measures

Primary Outcomes (1)

  • Serum IgG, IgA and IgM level

    6 months

Secondary Outcomes (1)

  • Drug side effects

    6 months

Study Arms (1)

lipitor

EXPERIMENTAL

atorvastatin 20mg daily

Drug: Lipitor

Interventions

LipitorDRUG

Atorvastatin 20mg daily for 6 months

Also known as: atorvastatin, statins
lipitor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
  • Accepting to participate in the study

You may not qualify if:

  • Refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Mohammadi hospital

Bandar Abbas, Hormozgan, 79176, Iran

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

AtorvastatinHydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic 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 AcidsLipidsAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Hamidreza Mahboobi

    Hormozgan University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

January 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2010

Last Updated

March 1, 2011

Record last verified: 2006-01

Locations

IR(1)