Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis

Efficacy and Safety of Jinshuibao for Patients With Chronic Kidney Disease Due to Glomerulonephritis：A Multicenter Randomized Controlled Clinical Trial

This is a multicenter, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis, with a planned follow-up of 48 weeks.

Study Overview

• Status: Unknown
• Conditions: Glomerulonephritis; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 3B
• Intervention / Treatment: Drug: Jinshuibao; Drug: Placebo

Detailed Description

Previous studies have shown that cordyceps sinensis can act on several immune response pathways. Jinshuibao capsule, which is composed of fermented cordyceps sinensis powder (Cs-4) , has shown therapeutic effects in chronic kidney disease (CKD) according to small sample exploratory studies. Here, we conduct a prospective, double-blind randomized controlled study to assess the efficacy and safety of Jinshuibao for patients with CKD due to glomerulonephritis.

• Study Type: Interventional
• Enrollment (Anticipated): 332
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged >= 18 years old and <= 70 years old.
2. Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
3. Chronic kidney disease stage 3b-4, that is, patients with eGFR between 15 and 45 ml/min per 1.73 m2 (according to 2012 KDIGO standard).
4. 24-hour urinary protein < 3g during the screening period.
5. Blood pressure, glucose, lipid and uric acid were measured during the screening period and were all in the following range: blood pressure: systolic blood pressure <140 and diastolic blood pressure < 90 mmHg; fasting blood-glucose < 8.0mmol/L or HbA1c < 8.0%; LDLl-c < 100 mg /dl (2.59 mmol/L), and TC < 230 mg /dl (5.95 mmol/L); uric acid < 420 mol/L.
6. Patients who have signed the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
2. Allergy to Jinshuibao.
3. Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
4. Treatment with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in recent 3 months, or patients who have been confirmed to be treated with glucocorticoids, immunosuppressants or tripterygium wilfordii preparations in the following months.
5. History of gastrointestinal impairment or gastrointestinal diseases which may significantly affect the absorption of the experimental drugs, such as confirmed active ulcer (Forrest grade II or more severe impairment), inflammatory bowel disease, malabsorption syndrome, uncontrollable diarrhea or history of gastrointestinal surgery.
6. History of organ transplant, including kidney transplant.
7. History of severe diseases of the heart, brain, liver, hematopoietic system or other serious diseases affecting survival, such as malignant tumors, myocardial infarction, unstable angina, stroke or transient ischemic attack in recent 6 months.
8. Patients whose disease progresses too rapidly judged by the clinician.
9. Enrolled in other trials in recent 3 months.
10. Patients who are assessed by investigator as unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; basic treatment combined with Jinshuibao	Drug: Jinshuibao; 6 capsules at a time, 3 times a day (tid).; Other Names: basic treatment
Placebo Comparator: Control group; basic treatment and placebo	Drug: Placebo; 6 capsules at a time, 3 times a day (tid).; Other Names: basic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of estimated glomerular filtration rate	Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation	Baseline to 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of surem creatinine and 24-hour urine protein	Surem creatinine (Scr) will be tested by a central laboratory	Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of urinary protein/creatinine ratio (PCR)	Change from baseline in PCR	Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks
Change of hs-CRP	Change from baseline in hs-CRP	Baseline to 24 weeks, 48 weeks
Change of TNF-α, IL-1β, and IL-6	Change from baseline in TNF-α, IL-1β, and IL-6	Baseline to 24 weeks and 48 weeks
Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD	End stage renal disease (ESRD）is defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min	48 weeks
Patients' Quality of life	Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version)	Baseline to 24 weeks and 48 weeks
Number of rehospitalizations	Number of rehospitalizations during the follow-up period	48 weeks

Collaborators and Investigators

• Sponsor: Jemincare
• Collaborators: Shanghai 6th People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2020
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Nephritis; Kidney Diseases; Renal Insufficiency, Chronic; Glomerulonephritis
• Other Study ID Numbers: NE-JSB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No