The Effects of TMZ on Diabetic Nephropathy

• Sponsor: Tongji Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05147194
• Collaborator: (none)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Drug: Trimetazidine	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effects of Trimetazidine on Diabetic Nephropathy
• Anticipated Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ratio of UACR levels at 6 months to baseline UACR [6 month]

   UACR(6 M)/UACR（base）

Secondary Outcome Measures

1. Serum creatinine [6 month]

   Serum creatinine

2. 24h urine protein level [6 month]

   24h urine protein level

3. Proportion of patients with UACR>300 mg/g in the population at 6 months [6 month]

   Proportion of patients with UACR>300 mg/g in the population at 6 months

4. Proportion of patients with UACR >30mg/g and <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

5. Ratio of UACR levels at 3 months to baseline UACR [3 month]

   Ratio of UACR levels at 3 months to baseline UACR

6. Ratio of UACR levels at 1 months to baseline UACR [1 month]

   Ratio of UACR levels at 1 months to baseline UACR

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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);

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tongji Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tongji Hospital
• ClinicalTrials.gov Identifier: NCT05147194
• Other Study ID Numbers: TJ-DN-TMZ
• First Posted: Dec 7, 2021
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Kidney Diseases; Diabetic Nephropathies; Trimetazidine

Study Results

No Results Posted as of Dec 7, 2021