Status:
COMPLETED
Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Urologic Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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-controll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00227409
Start Date
November 1 2001
End Date
October 1 2005
Last Update
October 18 2006
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chang Gung Memorial Hospital
Taipei, Taiwan, China, 105