Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Jinshuibao Capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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 | Drug: Jinshuibao Capsule<br>* 1.98g t.i.d. p.o. for 6 months<br>* Other names: Artificial Cordyceps sinensis powder;|
| No Intervention: Control Group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline and 1,2,3,6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)]. | half a year | 
| Change in urine α1-microglobulin. |  | Baseline and 1,2,3,6 months. | 
| Change in urine β2-microglobulin. |  | Baseline and 1,2,3,6 months. | 
| Change in urine N-acetyl-β-D-glucosidase. |  | Baseline and 1,2,3,6 months. | 
| Change in urine neutrophil gelatinase-associated lipocalin. |  | Baseline and 1,2,3,6 months. | 
| Change in inflammation level. | Change in hs-CRP level. | Baseline and 1,2,3,6 months. | 
| Change in HbA1c. |  | Baseline and 1,3,6 months. | 
| Change in blood pressure control. |  | Baseline and 1,2,3,6 months. | 
| Change in blood lipids. |  | Baseline and 1,3,6 months. | 
| Life quality evaluation | Change in SF-36 Scale score. | Baseline and 6 months. | 
| 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. | half a year |