The Effects of TMZ on Diabetic Nephropathy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Nephropathies
• Intervention / Treatment: Drug: Trimetazidine

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Older than 18 years of age;
2. Type 2 diabetes mellitus;
3. EGFR ≥30 to <90 ml/min/1.73 m2;
4. Urinary albumin creatinine ratio (UACR) ≥ 30 mg/g;

Exclusion Criteria:

1. Women who are already pregnant or planning to become pregnant;
2. SBP >180mmHg and/or DBP >110mmHg;
3. UACR ≥ 3000 mg/g
4. Other non-diabetic renal diseases (such as polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.);
5. NYHA cardiac function grade III or above
6. Those who have a history of cancer or are currently suffering from cancer;
7. Receiving immunosuppressant, cytotoxic or other immunosuppressive therapy in the first 6 months;
8. Patients with acute coronary syndrome, acute cardiac insufficiency or severe cerebrovascular disease in the previous month;
9. Patients refused to comply with the requirements of the study to complete the study;
10. 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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Blank group
Experimental: Trimetazidine group; The participates received treatments of trimetazidine	Drug: Trimetazidine; Oral，35mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of UACR levels at 6 months to baseline UACR	UACR(6 M)/UACR（base）	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum creatinine	Serum creatinine	6 month
24h urine protein level	24h urine protein level	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	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	6 month
Ratio of UACR levels at 3 months to baseline UACR	Ratio of UACR levels at 3 months to baseline UACR	3 month
Ratio of UACR levels at 1 months to baseline UACR	Ratio of UACR levels at 1 months to baseline UACR	1 month

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): December 7, 2021
• Last Update Submitted That Met QC Criteria: November 24, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies; Vasodilator Agents; Trimetazidine
• Other Study ID Numbers: TJ-DN-TMZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No