NCT07706946

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

2.4 years

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Lead-Burdened Type 2 Diabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

  • Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months follow-up after intravenous lead chelation therapy

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

Study Arms (1)

ntravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

EXPERIMENTAL
Drug: chelator

Interventions

chelatorDRUG

Calcium Disodium Edetate Injection

ntravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Chelating Agents

Intervention Hierarchy (Ancestors)

Sequestering AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Central Study Contacts

Xin Li

CONTACT

0579-89935390903706017@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share