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Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

Primary Purpose

Type 2 Diabetes Mellitus, Diabetic Kidney Disease

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Jinshuibao Capsule

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with written informed consent.
Type 2 diabetes according to 1999 WHO criteria.
Age: 30-75 years.
HbA1c < 11%.
Stage III diabetic kidney disease:
5.1 microalbuminuria: 30 mg / g < urinary albumin creatinine ratio (ACR) < 300 mg / g, positive for at least two in three times.
5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡.
Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months.
Childbearing-age women with contraceptive measures.

Exclusion Criteria：

Type 1 Diabetes Mellitus.
Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.)
Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.]
Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc.
Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.
Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.

Sites / Locations

The Second Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Treatment：subjects receive Jinshuibao Capsule. ARB will be continued as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling

Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling

Outcomes

Primary Outcome Measures

Change in urine albumin creatine ratio (ACR).

First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).

Secondary Outcome Measures

The incidence of ≧30% decline in eGFR from baseline.

Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) [CKD-EPI creatinine-cystatin equation (2012)].

Change in urine α1-microglobulin.

Change in urine β2-microglobulin.

Change in urine N-acetyl-β-D-glucosidase.

Change in urine neutrophil gelatinase-associated lipocalin.

Change in inflammation level.

Change in hs-CRP level.

Change in HbA1c.

Change in blood pressure control.

Change in blood lipids.

Life quality evaluation

Change in SF-36 Scale score.

Incidence of Treatment-Emergent Adverse Events

Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.

Full Information

NCT ID

NCT03164785

First Posted

May 8, 2017

Last Updated

December 7, 2020

Sponsor

Second Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03164785

Brief Title

Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

Official Title

Efficacy and Safety of Jinshuibao Capsule as Add-on Therapy to Angiotensin II Receptor Blockers on Diabetic Kidney Disease in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 24, 2017 (Actual)

Primary Completion Date

September 26, 2020 (Actual)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Second Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate the therapeutic effect and safety of Jinshuibao Capsule on diabetic kidney disease in T2DM patients.

Detailed Description

Diabetic Kidney Disease (DKD) is one of the most important microvascular complications of diabetes and is the leading cause of end-stage renal disease. Intensive glycemic and blood pressure control, combined with renin - angiotensin system blocking therapy (including ACEI and ARB drugs), has to a certain extent, delayed the progression of DKD, but still cannot completely block its development. Cordyceps sinensis is a traditional Chinese medicine and Jinshuibao Capsule is its artificial preparation, with the effect of renoprotection. However, its clinical application in diabetic kidney disease is not well-defined so far. The aim of this study is to investigate the potential use of Jinshuibao Capsule on microalbuminuria in T2DM.

6. Conditions and Keywords

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

Type 2 Diabetes Mellitus, Diabetic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

202 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Patients receive a standard dose of ARB drug as a routine therapy. Counseling: subjects will follow through regular check-up and receive lifestyle and other diabetes treatment counseling

Intervention Type

Drug

Intervention Name(s)

Jinshuibao Capsule

Other Intervention Name(s)

Jinshuibao Jiaonang, Cordyceps sinensis, Artificial Cordyceps sinensis powder

Intervention Description

1.98g t.i.d. p.o. for 6 months

Primary Outcome Measure Information:

Title

Change in urine albumin creatine ratio (ACR).

Description

First morning urine (10-15ml) of the subject is collected with a clean urine collection tube (or vial).

Time Frame

Baseline and 1,2,3,6 months.

Secondary Outcome Measure Information:

Title

The incidence of ≧30% decline in eGFR from baseline.

Description

Monitoring changes in glomerular functions measured in estimated glomerular filtration rate (eGFR) [CKD-EPI creatinine-cystatin equation (2012)].

Time Frame

half a year

Title

Change in urine α1-microglobulin.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in urine β2-microglobulin.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in urine N-acetyl-β-D-glucosidase.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in urine neutrophil gelatinase-associated lipocalin.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in inflammation level.

Description

Change in hs-CRP level.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in HbA1c.

Time Frame

Baseline and 1,3,6 months.

Title

Change in blood pressure control.

Time Frame

Baseline and 1,2,3,6 months.

Title

Change in blood lipids.

Time Frame

Baseline and 1,3,6 months.

Title

Life quality evaluation

Description

Change in SF-36 Scale score.

Time Frame

Baseline and 6 months.

Title

Incidence of Treatment-Emergent Adverse Events

Description

Treatment-related adverse events as assessed by deterioration of liver functions with other reasons excluded, self-report of gastrointestinal symptoms associated with drug intake, etc.

Time Frame

half a year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with written informed consent. Type 2 diabetes according to 1999 WHO criteria. Age: 30-75 years. HbA1c < 11%. Stage III diabetic kidney disease: 5.1 microalbuminuria: 30 mg / g < urinary albumin creatinine ratio (ACR) < 300 mg / g, positive for at least two in three times. 5.2 renal function: eGFR ≧ 30 ml / min / 1.73 ㎡. Stable use of a standard dose of angiotensin II receptor blocker ≧ 3 months. Childbearing-age women with contraceptive measures. Exclusion Criteria： Type 1 Diabetes Mellitus. Non-diabetic urinary system diseases (Urinary tract obstruction, bladder emptying disorders, severe benign prostatic hyperplasia, renal vascular disease, post-renal transplantation, active urinary tract infection,etc.) Other serious diseases [severe hypertension ((defined as SBP > 200 mmHg and/or DBP > 110 mmHg, or requiring ≧3 anti-hypertensive drugs simultaneously), cardiovascular and cerebrovascular events within 6 months, autoimmune diseases implicating the urinary system, chronic or acute pancreatitis, malignancy, hepatic abnormalities (transaminase ≧ 3.0 x UNL), severe gastrointestinal diseases, other endocrine diseases affecting the urinary system, etc.] Allergic to Cordyceps sinensis, use of ACEIs, any use of Cordyceps sinensis preparations, systemic glucocorticoid treatment ≧ 7 days within a month, use of nephrotoxic drugs within 3 months, alcohol or psychotropic drug dependence, etc. Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions. Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiguang Zhou, MD/PhD

Organizational Affiliation

Second Xiangya Hospital, Central South University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Xiangya Hospital of Central South University

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410011

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The results belongs to the principal investigator and collaborators.

Learn more about this trial

Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

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