Diabetic NephropathiesPhase 2NCT05147194
The Effects of TMZ on Diabetic Nephropathy
A Phase 2 study testing Trimetazidine in people with Diabetic Nephropathies, run by Tongji Hospital.
Trial summary
With the improvement of people's living standard, the prevalence of Diabetes is increasing year by year. In present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Trimetazidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Older than 18 years of age;
- Type 2 diabetes mellitus;
- EGFR ≥30 to <90 ml/min/1.73 m2;
- Urinary albumin creatinine ratio (UACR) ≥ 30 mg/g;
Who cannot join
- Women who are already pregnant or planning to become pregnant;
- SBP >180mmHg and/or DBP >110mmHg;
- UACR ≥ 3000 mg/g
- Other non-diabetic renal diseases (such as polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.);
- NYHA cardiac function grade III or above
- Those who have a history of cancer or are currently suffering from cancer;
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- Receiving immunosuppressant, cytotoxic or other immunosuppressive therapy in the first 6 months;
- Patients with acute coronary syndrome, acute cardiac insufficiency or severe cerebrovascular disease in the previous month;
- Patients refused to comply with the requirements of the study to complete the study;
- In the investigator's judgment, the patient is unable to complete the study or comply with the requirements of the study (for management reasons or other reasons);
About this study
Official title: The Effects of Trimetazidine on Diabetic Nephropathy
With the improvement of people's living standard, the prevalence of Diabetes is increasing year by year. In present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. Diabetes causes a variety of complications, including diabetic nephropathy, which is one of the most common complications of Diabetes. Diabetic nephropathy is a microvascular complication of diabetes. Microalbuminuria and glomerular filtration rate decrease are the main manifestation. Even more, it can progress to end-stage renal changes. Data showed that diabetic nephropathy accounts for about 40% of patients with end-stage renal disease receiving renal replacement therapy.
However, the treatment of diabetic nephropathy is still lacking. In the past 40 years, few drugs have been proven to ameliorate the progression of diabetic nephropathy. Even though, the renal function of a large number of diabetic nephropathy patients is gradually deteriorating. Therefore, it is urgent to find a therapeutic drug that acts on different targets.
Trimetazidine is a piperazine derivative. It is mainly used in the treatment of stable angina pectoris. Its safety has been well verified. In recent years, the role of trimetazidine in acute renal damage has been widely reported. A large number of studies have shown that trimetazidine can reduce the effect of contrast agent on renal function and reduce the incidence of contrast nephropathy. There fore, Trimetazidine is a promising drug for delaying the progression of diabetic nephropathy.
Read the detailed description
In the present study, there will be 2 groups last for 6 months. One is the control group, who will not receive trimetazidine and the another is the trimetazidine group, who will receive the treatment of trimetazidine, 35mg bid orally.
- Conditions
- Diabetic Nephropathies
- Being tested
- Trimetazidine
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrimetazidineDrug
Oral，35mg bid
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Blank group |
| Trimetazidine group | Experimental | The participates received treatments of trimetazidine Receives: Drug: Trimetazidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of UACR levels at 6 months to baseline UACR
UACR(6 M)/UACR（base）
Measured: 6 month
Secondary outcomes (6)
Serum creatinine
Serum creatinine
Measured: 6 month
24h urine protein level
24h urine protein level
Measured: 6 month
Proportion of patients with UACR>300 mg/g in the population at 6 months
Proportion of patients with UACR>300 mg/g in the population at 6 months
Measured: 6 month
Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months
Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months
Measured: 6 month
Ratio of UACR levels at 3 months to baseline UACR
Ratio of UACR levels at 3 months to baseline UACR
Measured: 3 month
Ratio of UACR levels at 1 months to baseline UACR
Ratio of UACR levels at 1 months to baseline UACR
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147194
- Sponsor's protocol ID
- TJ-DN-TMZ
- Status last verified
- Nov 2021
- First submitted
- 24 Nov 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trimetazidine on Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT05147194
- Acronym / sponsor ID
- TJ-DN-TMZ
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Dec 2021 (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.
With the improvement of people's living standard, the prevalence of Diabetes is increasing year by year. In present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. Diabetes causes a variety of complications, including diabetic nephropathy, which is one of the most common complications of Diabetes. Diabetic nephropathy is a microvascular complication of diabetes. Microalbuminuria and glomerular filtration rate decrease are the main manifestation. Even more, it can progress to end-stage renal changes. Data showed that diabetic nephropathy accounts for about 40% of patients with end-stage renal disease receiving renal replacement therapy.
However, the treatment of diabetic nephropathy is still lacking. In the past 40 years, few drugs have been proven to ameliorate the progression of diabetic nephropathy. Even though, the renal function of a large number of diabetic nephropathy patients is gradually deteriorating. Therefore, it is urgent to find a therapeutic drug that acts on different targets.
Trimetazidine is a piperazine derivative. It is mainly used in the treatment of stable angina pectoris. Its safety has been well verified. In recent years, the role of trimetazidine in acute renal damage has been widely reported. A large number of studies have shown that trimetazidine can reduce the effect of contrast agent on renal function and reduce the incidence of contrast nephropathy. There fore, Trimetazidine is a promising drug for delaying the progression of diabetic nephropathy.
Detailed description
In the present study, there will be 2 groups last for 6 months. One is the control group, who will not receive trimetazidine and the another is the trimetazidine group, who will receive the treatment of trimetazidine, 35mg bid orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Blank group |
| Trimetazidine group | Experimental | Drug: TrimetazidineThe participates received treatments of trimetazidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 years of age;
- Type 2 diabetes mellitus;
- EGFR ≥30 to <90 ml/min/1.73 m2;
- Urinary albumin creatinine ratio (UACR) ≥ 30 mg/g;
Key exclusion criteria (10 listed)
- Women who are already pregnant or planning to become pregnant;
- SBP >180mmHg and/or DBP >110mmHg;
- UACR ≥ 3000 mg/g
- Other non-diabetic renal diseases (such as polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.);
- NYHA cardiac function grade III or above
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 |
|---|---|---|
| TrimetazidineOral，35mg bid | Drug | Trimetazidine group |
Primary outcome
Ratio of UACR levels at 6 months to baseline UACR
Time frame: 6 month
UACR(6 M)/UACR（base）
6 secondary outcomes
Serum creatinine
Time frame: 6 month
24h urine protein level
Time frame: 6 month
Proportion of patients with UACR>300 mg/g in the population at 6 months
Time frame: 6 month
Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months
Time frame: 6 month
Ratio of UACR levels at 3 months to baseline UACR
Time frame: 3 month
Ratio of UACR levels at 1 months to baseline UACR
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimetazidine in people with Diabetic Nephropathies, run by Tongji Hospital.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Dec 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of UACR levels at 6 months to baseline UACR (time frame: 6 month). 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 7 Dec 2021.