Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Information source: Chang Gung Memorial Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urologic Disease
Intervention: calcium disodium EDTA (edetate calcium disodium) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Chang Gung Memorial Hospital Official(s) and/or principal investigator(s):
Ja-Liang Lin, MD, Principal Investigator, Affiliation: Division of Nephrology, Chang Gung Memorial Hospital
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.
Clinical Details
Official title: Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden
Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment
Primary outcome: The primary end point was an increase in serum creatinine to 2 times the base-line value or the need for dialysis.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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.
Locations and Contacts
Chang Gung Memorial Hospital, Taipei, Taiwan 105, China
Additional Information
Starting date: November 2001
Ending date: October 2005
Last updated: October 17, 2006
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