A Prospective Trial Of Oral Lead Chelation To Slow Renal Function Decline In Lead-Loaded Type 2 Diabetic Nephropathy Patients

A Prospective Study On The Effect Of Oral Chelator Therapy On Delaying Renal Function Progression In Type 2 Diabetic Nephropathy Patients With Elevated Lead Burden

This is a single-arm prospective clinical study conducted at The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Previous basic research has found that patients with type 2 diabetic nephropathy have higher blood lead levels than ordinary people, and lead accumulation may accelerate kidney function decline. A total of 42 eligible participants will be enrolled, who are diagnosed with type 2 diabetic nephropathy, have baseline blood lead ≥5 µg/dl, CKD stage ≤3 and 24-hour urinary protein <8 g. All subjects will receive oral dimercaptosuccinic acid (DMSA) capsules for lead removal according to standardized treatment courses for up to 3 months. During treatment, blood lead, urine lead, renal function and other indicators will be tested monthly. After the 3-month intervention, all participants will be followed up for 12 months, with relevant laboratory examinations conducted every 3 months to observe changes in renal function. The main goal of this study is to evaluate whether oral lead chelation therapy can slow the progression of kidney damage in patients with high lead burden and type 2 diabetic nephropathy, and provide clinical evidence for the intervention of lead-induced kidney injury in diabetic populations. Patients with hypertension, hyperlipidemia, autoimmune diseases, malignant tumor history, previous occupational lead exposure or drug allergies will not be enrolled. No healthy volunteers will be recruited, and individual raw patient data will not be shared externally after the study.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden
• Intervention / Treatment: Drug: Dimercaptosuccinic acid oral chelation therapy

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Li; Phone Number: 0579-89935390; Email: 903706017@qq.com

Participation Criteria

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;
6. Able to voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Combined hypertension or hyperlipidemia;
2. Confirmed history of autoimmune diseases;
3. Personal history of malignant tumors;
4. Reversible renal insufficiency (malignant hypertension, active urinary tract infection, recent use of nephrotoxic drugs);
5. Previous occupational lead exposure history;
6. Known drug allergy to dimercaptosuccinic acid;
7. Unable to complete regular follow-up visits.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Oral Dimercaptosuccinic Acid Chelation Treatment Arm

Drug: Dimercaptosuccinic acid oral chelation therapy; Oral dimercaptosuccinic acid capsules with two optional oral dosing regimens for lead removal in lead-loaded type 2 diabetic nephropathy patients. The treatment lasts up to 3 months with regular monthly laboratory monitoring, followed by 12-month follow-up to observe renal function changes, differing from intravenous chelation intervention in other studies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months after oral chelation therapy	3 months oral chelation intervention, followed by 12 months of quarterly follow-up assessment, with the primary endpoint measured at the 12-month post-treatment visit

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

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 16, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY-2025-377

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