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Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

Primary Purpose

Urologic Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
calcium disodium EDTA (edetate calcium disodium)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urologic Disease focused on measuring Repeated chelation therapy, Progressive renal insufficiency, Body lead burden, Long-term outcome, Glomerular filtration rate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients from 18 through 80 years of age who had chronic renal insufficiency were eligible if they had a serum creatinine concentration between 1.5 mg per deciliter (132.6 μmol per liter) and 3.9 mg per deciliter (344.8 μmol per liter), with a decrease in the glomerular filtration rate of less than 5 ml per minute over a period of at least six months Blood pressure less than 140/90 mm Hg A cholesterol level below 240 mg per deciliter Daily protein intake under 1 g per kilogram of body weight No known history of exposure to lead or other heavy metals, and a high-normal body lead burden (between 60 and 600 μg, as measured by EDTA mobilization testing and 72-hour urine collection). Exclusion Criteria: Patients who have renal insufficiency with a potentially reversible cause, such as malignant hypertension, urinary tract infection, hypercalcemia, or drug-induced nephrotoxic effects Systemic diseases, such as connective-tissue diseases or diabetes mellitus Use of drugs that might alter the course of renal disease, such as nonsteroidal anti-inflammatory agents, steroids, or immunosuppressive drugs Rapidly progressive glomerulonephritis or a high level of 24-hour urinary protein excretion (more than 8 g per day) Previous marked exposure to lead and other metals(lead poisoning or occupational exposure) Drug allergies Absence of informed consent.

Sites / Locations

  • Chang Gung Memorial Hospital

Outcomes

Primary Outcome Measures

The primary end point was an increase in serum creatinine to 2 times the base-line value or the need for dialysis.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2005
Last Updated
October 17, 2006
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00227409
Brief Title
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Official Title
Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

5. Study Description

Brief Summary
Previous study showed repeated lead chelation therapy significant reduced progressive renal insufficiency in patients with chronic renal diseases and high-normal body lead burden in a placebo-controlled, randomized, 2-year clinical trial, even factors that influence progression, such as blood pressure, the presence or absence of hyperlipidemia, and urinary protein excretion were well controlled.Since relative small sample size and short duration of follow-up were noted in the previous study, whether repeated lead chelation therapy could long-term retard the progression of renal insufficiency remains unknown. Hence, we conducted a 51-month placebo-controlled clinical trial to assess the long-term effect of repeated chelation in progressive renal insufficiency of patients with high-normal body lead burden.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Disease
Keywords
Repeated chelation therapy, Progressive renal insufficiency, Body lead burden, Long-term outcome, Glomerular filtration rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
calcium disodium EDTA (edetate calcium disodium)
Primary Outcome Measure Information:
Title
The primary end point was an increase in serum creatinine to 2 times the base-line value or the need for dialysis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from 18 through 80 years of age who had chronic renal insufficiency were eligible if they had a serum creatinine concentration between 1.5 mg per deciliter (132.6 μmol per liter) and 3.9 mg per deciliter (344.8 μmol per liter), with a decrease in the glomerular filtration rate of less than 5 ml per minute over a period of at least six months Blood pressure less than 140/90 mm Hg A cholesterol level below 240 mg per deciliter Daily protein intake under 1 g per kilogram of body weight No known history of exposure to lead or other heavy metals, and a high-normal body lead burden (between 60 and 600 μg, as measured by EDTA mobilization testing and 72-hour urine collection). Exclusion Criteria: Patients who have renal insufficiency with a potentially reversible cause, such as malignant hypertension, urinary tract infection, hypercalcemia, or drug-induced nephrotoxic effects Systemic diseases, such as connective-tissue diseases or diabetes mellitus Use of drugs that might alter the course of renal disease, such as nonsteroidal anti-inflammatory agents, steroids, or immunosuppressive drugs Rapidly progressive glomerulonephritis or a high level of 24-hour urinary protein excretion (more than 8 g per day) Previous marked exposure to lead and other metals(lead poisoning or occupational exposure) Drug allergies Absence of informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ja-Liang Lin, MD
Organizational Affiliation
Division of Nephrology, Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
State/Province
Taiwan
ZIP/Postal Code
105
Country
China

12. IPD Sharing Statement

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Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

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