Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency - Full Text View

Sponsored by:	Chang Gung Memorial Hospital
Information provided by:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00227409

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)

MedlinePlus related topics: Calcium

Drug Information available for: Calcium gluconate Disodium edetate Edetate Calcium Disodium Edetate Disodium Edetic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment
Official Title:	Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	NMRPG3029, NSC93-2314-B-182A- 079
Study First Received:	September 26, 2005
Last Updated:	October 17, 2006
ClinicalTrials.gov Identifier:	NCT00227409
Health Authority:	Taiwan: Department of Health

Keywords provided by Chang Gung Memorial Hospital:

Repeated chelation therapy
Progressive renal insufficiency
Body lead burden
Long-term outcome
Glomerular filtration rate

Study placed in the following topic categories:

Calcium, Dietary
Renal Insufficiency
Urologic Diseases

Renal Insufficiency, Chronic
Kidney Diseases
Edetic Acid

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009