The Effects of TMZ on Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathies
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Trimetazidine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Nephropathies
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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);
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Trimetazidine group
Arm Description
Blank group
The participates received treatments of trimetazidine
Outcomes
Primary Outcome Measures
Ratio of UACR levels at 6 months to baseline UACR
UACR(6 M)/UACR(base)
Secondary Outcome Measures
Serum creatinine
Serum creatinine
24h urine protein level
24h urine protein level
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
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
Ratio of UACR levels at 3 months to baseline UACR
Ratio of UACR levels at 3 months to baseline UACR
Ratio of UACR levels at 1 months to baseline UACR
Ratio of UACR levels at 1 months to baseline UACR
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05147194
Brief Title
The Effects of TMZ on Diabetic Nephropathy
Official Title
The Effects of Trimetazidine on Diabetic Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Blank group
Arm Title
Trimetazidine group
Arm Type
Experimental
Arm Description
The participates received treatments of trimetazidine
Intervention Type
Drug
Intervention Name(s)
Trimetazidine
Intervention Description
Oral,35mg bid
Primary Outcome Measure Information:
Title
Ratio of UACR levels at 6 months to baseline UACR
Description
UACR(6 M)/UACR(base)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Serum creatinine
Description
Serum creatinine
Time Frame
6 month
Title
24h urine protein level
Description
24h urine protein level
Time Frame
6 month
Title
Proportion of patients with UACR>300 mg/g in the population at 6 months
Description
Proportion of patients with UACR>300 mg/g in the population at 6 months
Time Frame
6 month
Title
Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months
Description
Proportion of patients with UACR >30mg/g and <300 mg/g in the population at 6 months
Time Frame
6 month
Title
Ratio of UACR levels at 3 months to baseline UACR
Description
Ratio of UACR levels at 3 months to baseline UACR
Time Frame
3 month
Title
Ratio of UACR levels at 1 months to baseline UACR
Description
Ratio of UACR levels at 1 months to baseline UACR
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
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);
12. IPD Sharing Statement
Learn more about this trial
The Effects of TMZ on Diabetic Nephropathy
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