Chronic Kidney DiseaseNCT01305317
Effect of Statins on IgG, IgA and IgM Level in Chronic Hemodialysis Patients
A study testing Lipitor in people with Chronic Kidney Disease, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Lipitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
- Accepting to participate in the study
Who cannot join
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
This is double blind randomized controlled trial on the statins effects on serum IgG, IgA and IgM level in chronic hemodialysis patients in Bandarabbas
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Lipitor
- Keywords
- Statin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipitorDrug
Also called atorvastatin, statins
Atorvastatin 20mg daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| lipitor | Experimental | atorvastatin 20mg daily Receives: Drug: Lipitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG, IgA and IgM level
Measured: 6 months
Secondary outcomes (1)
Drug side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Hamidreza Mahboobi, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305317
- Sponsor's protocol ID
- statins and Immunoglobulins
- Status last verified
- Jan 2006
- First submitted
- 25 Feb 2011
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Statins' Effect on Serum IgG, IgA Ang IgM Level in Chronic Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01305317
- Acronym / sponsor ID
- statins and Immunoglobulins
- Conditions
- Chronic Kidney Disease
- Keywords
- Statin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lipitor | Experimental | Drug: Lipitoratorvastatin 20mg daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All chronic hemodialysis patients attending Shahid Mohammadi hospital during the study period
- Accepting to participate in the study
Key exclusion criteria (1 listed)
- Refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipitorAlso: atorvastatin, statinsAtorvastatin 20mg daily for 6 months | Drug | lipitor |
Primary outcome
Serum IgG, IgA and IgM level
Time frame: 6 months
1 secondary outcome
Drug side effects
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamidreza Mahboobi principal investigator
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipitor in people with Chronic Kidney Disease, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgG, IgA and IgM level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.