Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03164785
• Other study ID #: JSB201601
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 24, 2017
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2024
• Source: Second Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: December 8, 2022
• Est. primary completion date: September 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects with written informed consent.

2. Type 2 diabetes according to 1999 WHO criteria.

3. Age: 30-75 years.

4. HbA1c < 11%.

5. 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 ?.

6. Stable use of a standard dose of angiotensin II receptor blocker ? 3 months.

7. Childbearing-age women with contraceptive measures.

Exclusion Criteria:

1. Type 1 Diabetes Mellitus.

2. 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.)

3. 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.]

4. 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.

5. Presence of acute metabolic disorders (DKA,HHS); history of surgery, severe trauma and other stress conditions.

6. Female patients who are pregnant or breastfeeding. Any medical condition that, in the opinion of the investigator, will interfere with participation in the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Jinshuibao Capsule
1.98g t.i.d. p.o. for 6 months

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Second Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in urine a1-microglobulin.		Baseline and 1,2,3,6 months.
Secondary	Change in urine ß2-microglobulin.		Baseline and 1,2,3,6 months.
Secondary	Change in urine N-acetyl-ß-D-glucosidase.		Baseline and 1,2,3,6 months.
Secondary	Change in urine neutrophil gelatinase-associated lipocalin.		Baseline and 1,2,3,6 months.
Secondary	Change in inflammation level.	Change in hs-CRP level.	Baseline and 1,2,3,6 months.
Secondary	Change in HbA1c.		Baseline and 1,3,6 months.
Secondary	Change in blood pressure control.		Baseline and 1,2,3,6 months.
Secondary	Change in blood lipids.		Baseline and 1,3,6 months.
Secondary	Life quality evaluation	Change in SF-36 Scale score.	Baseline and 6 months.
Secondary	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