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

Jemincare

Status and phase: Unknown; Phase 4

Conditions: Glomerulonephritis; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 3B

Treatments: Drug: Jinshuibao; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04349683

NE-JSB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 332 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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332 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

basic treatment combined with Jinshuibao

Treatment:

Drug: Jinshuibao

Control group

Placebo Comparator group

Description:

basic treatment and placebo

Treatment:

Drug: Placebo