- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00926406
Environmental Exposure to Lead and Its Health Effects on Patients With Maintenance Hemodialysis
April 5, 2010 updated by: Chang Gung Memorial Hospital
One thousand patients with LHD who have no history of exposure to lead will be observed for 18 months.
Blood lead level(BLL), biochemical data, hemoglobin, albumin, Cr, high sensitivity C-reactive protein (HsCRP), and blood cell counts are assessed at baseline.
The morbidity and mortality are recorded in detail.
Then, one hundred subjects with high BLL (>20μg/dl) will be randomly assigned to the study and control groups.
For 3-6 months, the 50 patients in the study group will receive lead-chelation therapy with calcium disodium EDTA weekly until the BLB falls below BLL< 5 μg/dl, and the 50 control group patients receive weekly placebo for 12 weeks.
During the ensuing 18 months, the BLL, biochemical data will be regularly followed up every 3 months.
BLL is measured every 6 months.
If BLL of the study group patients increase >10 μg/dl, the chelation therapy will be performed again until their BLL is <5 μg/dl.
The primary end point is morbidity or mortality during the observation and follow-up period.
A secondary end point is the change in hemoglobin, albumin, Cr and Hs CRP during the follow up period.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ja-Liang Lin, MD
- Phone Number: 8892 886-3-3281300
- Email: jllin@adm.cgmh.org.tw
Study Locations
-
-
-
Taoyuan, Taiwan, 33333
- Recruiting
- Chang Gung Memorial Hospital
-
Contact:
- Tsang-Tang Hsieh, MD
- Email: tth3388@adm.cgmh.org.tw
-
Principal Investigator:
- Ja-Liang Lin, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- MHD patients have dialyzed for more than 6 months and age >18 and < 90 year-old
Exclusion Criteria:
- Patients with malignancies and obvious infectious diseases as well as those who are hospitalized or underwent surgery or renal transplantation within the 3 months preceding the investigation;Patients with a history of occupational exposure to heavy metals, metal intoxication, living in metal-contaminated areas were also excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary end point is morbidity or mortality during the follow-up period.
Time Frame: 18 months follow-up period
|
18 months follow-up period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A secondary end point is the change in HB, albumin, Cr and Hs CRP during the follow up period.
Time Frame: 18 months follow-up period
|
18 months follow-up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Anticipated)
October 1, 2011
Study Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
June 21, 2009
First Submitted That Met QC Criteria
June 22, 2009
First Posted (Estimate)
June 23, 2009
Study Record Updates
Last Update Posted (Estimate)
April 7, 2010
Last Update Submitted That Met QC Criteria
April 5, 2010
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 96-1455C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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