Long-Term Lead Chelation Therapy and Progressive Renal Insufficiency

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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Key information

Conditions

Urologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taipei, Taiwan, 105, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

calcium disodium EDTA (edetate calcium disodium)

Drug

Primary outcomes

The primary end point was an increase in serum creatinine to 2 times the base-line value or the need for dialysis.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Long-Term Repeated Lead Chelation Therapy in Non-Diabetic Patients With Chronic Renal Insufficiency and High-Normal Body Lead Burden

Important dates

Study start: 2001
Study completion: 2005
First posted: Sep 28, 2005
Registry last updated: Oct 18, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed