Intravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • chelator

    Drug

    Calcium Disodium Edetate Injection

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: ntravenous Chelators in Lead-Burdened Type 2 Diabetic NephropathyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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