Efficacy and Safety of Jinshuibao Capsule on Diabetic Kidney Disease

NCT03164785 | Completed Phase 2 DMC

• 1 other identifier: JSB201601
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

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

  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.

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Jinshuibao Capsule DRUG

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

Also known as: Jinshuibao Jiaonang, Cordyceps sinensis, Artificial Cordyceps sinensis powder

Treatment Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with written informed consent.
• Type 2 diabetes according to 1999 WHO criteria.
• Age: 30-75 years.
• HbA1c \< 11%.
• Stage III diabetic kidney disease:
• microalbuminuria: 30 mg / g \< urinary albumin creatinine ratio (ACR) \< 300 mg / g, positive for at least two in three times.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Interventions

CME-1 polysaccharide, Cordyceps sinensis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Study Officials

• Zhiguang Zhou, MD/PhD

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endocrinology Department

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 24, 2017
• Study Start: July 24, 2017
• Primary Completion: September 26, 2020
• Study Completion: December 8, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)