Type 2 Diabetic Nephropathy With Elevated Blood Lead BurdenNCT07709871
A Prospective Trial Of Oral Lead Chelation To Slow Renal Function Decline In Lead-Loaded Type 2 Diabetic Nephropathy Patients
A study testing Dimercaptosuccinic acid oral chelation therapy in people with Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden
- What is being tested?
- Dimercaptosuccinic acid oral chelation therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetic nephropathy;
- Baseline blood lead level ≥ 5 μg/dL;
- Chronic kidney disease stage ≤ 3;
- 24-hour urinary protein < 8 g;
- Age ≥ 18 years;
- Able to voluntarily sign a written informed consent form.
Who cannot join
- Combined hypertension or hyperlipidemia;
- Confirmed history of autoimmune diseases;
- Personal history of malignant tumors;
- Reversible renal insufficiency (malignant hypertension, active urinary tract infection, recent use of nephrotoxic drugs);
- Previous occupational lead exposure history;
- Known drug allergy to dimercaptosuccinic acid;
- Unable to complete regular follow-up visits.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Dimercaptosuccinic acid oral chelation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimercaptosuccinic acid oral chelation therapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Dimercaptosuccinic Acid Chelation Treatment Arm | Experimental | Not described Receives: Drug: Dimercaptosuccinic acid oral chelation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months after oral chelation therapy
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetic Nephropathy With Elevated Blood Lead BurdenStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709871
- Sponsor's protocol ID
- KY-2025-377
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07709871
- Acronym / sponsor ID
- KY-2025-377
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Dimercaptosuccinic Acid Chelation Treatment Arm | Experimental | Drug: Dimercaptosuccinic acid oral chelation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetic nephropathy;
- Baseline blood lead level ≥ 5 μg/dL;
- Chronic kidney disease stage ≤ 3;
- 24-hour urinary protein < 8 g;
- Age ≥ 18 years;
Key exclusion criteria (7 listed)
- Combined hypertension or hyperlipidemia;
- Confirmed history of autoimmune diseases;
- Personal history of malignant tumors;
- Reversible renal insufficiency (malignant hypertension, active urinary tract infection, recent use of nephrotoxic drugs);
- Previous occupational lead exposure history;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimercaptosuccinic acid oral chelation therapyOral 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. | Drug | Oral Dimercaptosuccinic Acid Chelation Treatment Arm |
Primary outcome
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months after oral chelation therapy
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Dimercaptosuccinic acid oral chelation therapy in people with Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Li (0579-89935390, 903706017@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate (eGFR) from baseline at 12 months after oral chelation therapy (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.