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Not yet recruitingNCT07709871Updated Jul 17, 2026

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

An interventional study of Dimercaptosuccinic acid oral chelation therapy in Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Type 2 Diabetic Nephropathy With Elevated Blood Lead Burden
03

In context

Diabetic Nephropathies

543 studies on the registry are indexed under Diabetic Nephropathies; 110 are open to participants now.

This study's planned enrollment of 42 is below the median of 78 across 388 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 92 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

Exclusion Criteria:

  1. Combined hypertension or hyperlipidemia;
  2. Confirmed history of 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Oral Dimercaptosuccinic Acid Chelation Treatment Arm

    Drug: Dimercaptosuccinic acid oral chelation therapy

Interventions

  • DrugDimercaptosuccinic 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.

06

What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jan 2029, 29 months later.

Of 49 non-industry interventional studies with no phase under Diabetic Nephropathies, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's planned 29 months is above that.

Counting every sponsor, half of 50 studies reached it within 23 months; a quarter within 11 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2026
First posted
Jul 17, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
Jan 1, 2029
CompletionEst.
Jan 1, 2029
Last update
Jul 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07709871
Lead sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jan 1, 2029 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Jul 17, 2026

Study contacts

Xin Li
Contact
903706017@qq.com
0579-89935390

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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