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Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227409
First Posted: September 28, 2005
Last Update Posted: October 18, 2006
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.
Information provided by:
Chang Gung Memorial Hospital
  Purpose
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.

Condition Intervention
Urologic Disease Drug: calcium disodium EDTA (edetate calcium disodium)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

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.

Study Start Date: November 2001
Estimated Study Completion Date: October 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227409


Locations
China, Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, China, 105
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Ja-Liang Lin, MD Division of Nephrology, Chang Gung Memorial Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00227409     History of Changes
Other Study ID Numbers: NMRPG3029
NSC93-2314-B-182A- 079
First Submitted: September 26, 2005
First Posted: September 28, 2005
Last Update Posted: October 18, 2006
Last Verified: September 2005

Keywords provided by Chang Gung Memorial Hospital:
Repeated chelation therapy
Progressive renal insufficiency
Body lead burden
Long-term outcome
Glomerular filtration rate

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Kidney Diseases
Edetic Acid
Pentetic Acid
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents