RecruitingPhase 2

The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels

China11 participantsStarted 2025-07-07

Plain-language summary

This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
. Single morning urine cadmium \>5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
. eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).

Exclusion criteria

. Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
. Patients with a history of kidney disease requiring hemodialysis;
. Patients with a history of severe infusion-related allergic reactions, known allergies to three or more substances, or known hypersensitivity to any component of this product (e.g., disodium edetate, mannitol);
. Previous diagnosis of diabetes with poorly controlled blood glucose;
. History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
. High-risk uncontrolled arrhythmia within the past 6 months, including:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacodynamic Parameters , 24-hour urinary cadmium

Timeframe: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)

Trial details

NCT IDNCT07057414

SponsorGuangdong Jianersheng Pharmaceutical Technology Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-29

Contact for this trial

Xiaojiang Tang, PhD

13719282259 tangxiaojiang@jesgmdtc.com

View on ClinicalTrials.gov More Cadmium Exceeds the Standard trials