chelator
DrugCalcium Disodium Edetate Injection
Not Yet Recruiting
NCT Number: NCT07706946
Intravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy
Based on previous basic experiments revealing that patients with type 2 diabetic nephropathy exhibit higher blood lead levels than the general population, this study aims to systematically evaluate the impacts of short-term and long-term blood lead exposure on renal function progression in such patients, so as to provide novel epidemiological evidence for clinical intervention.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 1. Diagnosed with type 2 diabetic nephropathy; 2. Baseline blood lead level ≥5 µg/dl; 3. Chronic kidney disease stage ≤3; 4. 24-hour urinary protein < 8 g; 5. Age ≥18 years old; 6. Able to provide written informed consent.
Exclusion criteria
- 1. Combined hypertension; 2. Combined hyperlipidemia; 3. History of autoimmune diseases; 4. Personal history of malignant tumors; 5. Reversible renal insufficiency (malignant hypertension, urinary tract infection, recent use of nephrotoxic drugs); 6. Past occupational lead exposure history; 7. Drug allergy to calcium disodium edetate; 8. Unable to complete follow-up or provide informed consent.
Treatment and study plan
Primary outcomes
-
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months follow-up after intravenous lead chelation therapy
Time frame: 3 months of intravenous lead chelation intervention, followed by 12 months of follow-up assessment with detections every 3 months
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Other
Registry information
Official study title
A Prospective Study on Intravenous Chelator Therapy for Slowing Renal Function Progression in Patients With Type 2 Diabetic Nephropathy Combined With Lead Burden
Important dates
- Study start
- 2026
- Primary completion
- 2029
- Study completion
- 2029
- First posted
- Jul 16, 2026
- Registry last updated
- Jul 16, 2026
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.