Intravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

July 12, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

A Prospective Study on Intravenous Chelator Therapy for Slowing Renal Function Progression in Patients With Type 2 Diabetic Nephropathy Combined With Lead Burden

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ntravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy
Drug: chelator
Calcium Disodium Edetate Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months of intravenous lead chelation intervention, followed by 12 months of follow-up assessment with detections every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2025-379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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