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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
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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);

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

    First Posted
    November 24, 2021
    Last Updated
    November 24, 2021
    Sponsor
    Tongji Hospital
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    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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