Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00227409
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : October 18, 2006
Information provided by:
Chang Gung Memorial Hospital

September 26, 2005
September 28, 2005
October 18, 2006
November 2001
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The primary end point was an increase in serum creatinine to 2 times the base-line value or the need for dialysis.
Same as current
Complete list of historical versions of study NCT00227409 on Archive Site
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Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Urologic Disease
Drug: calcium disodium EDTA (edetate calcium disodium)
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2005
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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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
NSC93-2314-B-182A- 079
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Chang Gung Memorial Hospital
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Principal Investigator: Ja-Liang Lin, MD Division of Nephrology, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP