Intravenous Chelators in Lead-Burdened Type 2 Diabetic Ne... | NCT07706946

Studies
Intravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

NCT07706946

Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Status

Not yet recruiting

Last Update Posted

Jul 16, 2026Actual

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Lead-Burdened Type 2 Diabetic Nephropathy

Interventions

chelator

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Jan 1, 2029Estimated

Completion Date

Jan 1, 2029Estimated

First Submitted Date

Jul 12, 2026

First Submission Date that Met QC Criteria

Jul 12, 2026

First Posted Date

Jul 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 12, 2026

Last Update Posted Date

Jul 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ntravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy	Experimental		Drug: chelator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
chelator	Drug	Calcium Disodium Edetate Injection	ntravenous Chelators in Lead-Burdened Type 2 Diabetic Nephropathy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Xin Li	Contact	0579-89935390		903706017@qq.com

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002614	Chelating Agents

Ancestor Terms

ID	Term
D064449	Sequestering Agents
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided