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Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Kunxian capsule
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Conformed to the diagnostic criteria of diabetic nephropathy
  • No gender limitation, age 18-85 years old, no fertility requirement temporarily
  • eGFR: >30ml/min/1.73m2（CKD-EPI）
  • Urine protein >1 g/day
  • No glucocorticoids or/and immunosuppressive therapy was received within 3 months
  • Patients volunteered to participate in this study and signed the informed consent

Exclusion Criteria:

  • Combined with diabetic acute complications or acute kidney injury (AKI)
  • Combined with other autoimmune diseases
  • Primary and other secondary renal diseases
  • Patients with hypotension (BP < 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs
  • There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules
  • There are fertility requirements or pregnant, lactation patients
  • Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases
  • Kidney transplant or dialysis has been performed
  • Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits

Sites / Locations

  • First Affiliated Hospital of Xian Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

irbesartan tablet (150mg qd or 300mg qd) for 48 weeks

Outcomes

Primary Outcome Measures

Changed levels of urinary protein, gram
The effective remission time of urinary protein, day
Urinary protein remission rate, %

Secondary Outcome Measures

24-hour urinary protein quantity, gram
Urinary albumin/creatinine ratio
eGFR decline rate slope
Number of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, %
Time of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, days

Full Information

First Posted
July 1, 2021
Last Updated
June 30, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT04981613
Brief Title
Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Official Title
RCT Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators designed a randomized parallel controlled clinical study, selected 98 cases of diabetic nephropathy patients with urinary protein > 1g, randomly assigned into the Kunxian capsule + irbesartan group or irbesartan group, 48 weeks of treatment and follow-up, reduced levels of urinary protein and effective relief time, remission rate as the main end point, estimated glomerular filtration rate (eGFR) drop rate slope for secondary end points, safety events were also collected. To evaluate the efficacy and safety of Kunxian capsule combined with irbesartan in treatment of diabetic nephropathy compared with irbesartan alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Kunxian capsule
Intervention Description
Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
Primary Outcome Measure Information:
Title
Changed levels of urinary protein, gram
Time Frame
48 weeks
Title
The effective remission time of urinary protein, day
Time Frame
48 weeks
Title
Urinary protein remission rate, %
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
24-hour urinary protein quantity, gram
Time Frame
48 weeks
Title
Urinary albumin/creatinine ratio
Time Frame
48 weeks
Title
eGFR decline rate slope
Time Frame
48 weeks
Title
Number of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, %
Time Frame
48 weeks
Title
Time of participants achieving end stage renal disease (ESRD) or requiring dialysis or kidney transplantation, or blood creatinine doubling, or renal death, or all-cause death, days
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with treatment-related adverse events as assessed by bone marrow suppression, %
Time Frame
48 weeks
Title
Number of participants with treatment-related adverse events as assessed by liver damage, %
Time Frame
48 weeks
Title
Number of participants with treatment-related adverse events as assessed by infection, %
Time Frame
48 weeks
Title
Number of participants with treatment-related adverse events as assessed by gastrointestinal reactions, %
Time Frame
48 weeks
Title
Number of participants with treatment-related adverse events as assessed by skin damage, %
Time Frame
48 weeks
Title
Number of participants with treatment-related adverse events as assessed by reproductive toxicity (menorrhea or amenorrhea or infertility), %
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Conformed to the diagnostic criteria of diabetic nephropathy No gender limitation, age 18-85 years old, no fertility requirement temporarily eGFR: >30ml/min/1.73m2（CKD-EPI） Urine protein >1 g/day No glucocorticoids or/and immunosuppressive therapy was received within 3 months Patients volunteered to participate in this study and signed the informed consent Exclusion Criteria: Combined with diabetic acute complications or acute kidney injury (AKI) Combined with other autoimmune diseases Primary and other secondary renal diseases Patients with hypotension (BP < 90/60mmHg) or bilateral renal artery stenosis who are not suitable for angiotensin receptor blockers (ARB) drugs There are contraindications to the use of kunxian capsules or allergic to any of the ingredients in kunxian capsules There are fertility requirements or pregnant, lactation patients Combined with malignant tumor, hepatitis, tuberculosis, HIV, serious infection, rheumatic disease, heart failure, chronic obstructive pulmonary disease (COPD) and other serious systemic diseases Kidney transplant or dialysis has been performed Clinicians deem it inappropriate, or patients are unwilling to sign informed consent, have poor compliance, have a history of mental illness, or cannot complete follow-up visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Shen, MD, PHD
Phone
0086-18991978269
Email
shenyan66@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Juan Ya Gao, MD
Phone
0086-15122036218
Email
3167496249@qq.com
Facility Information:
Facility Name
First Affiliated Hospital of Xian Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Shen, MD, PHD
Phone
0086-18991978269
Email
shenyan66@126.com

12. IPD Sharing Statement

Learn more about this trial

Study on the Efficacy and Safety of a Novel Tripterygium Wilfordii Preparation in Reducing Proteinuria in Patients With Diabetic Nephropathy

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