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

J

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

  • Aged >= 18 years old and <= 70 years old.
  • Patients with chronic kidney disease caused by primary glomerulonephritis diagnosed by previous pathology or diagnosed by clinician.
  • 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).
  • 24-hour urinary protein < 3g during the screening period.
  • 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.
  • Patients who have signed the informed consent.

Exclusion criteria

  • Pregnant or lactating women, or women of reproductive age who are unwilling to take reliable contraceptive measures.
  • Allergy to Jinshuibao.
  • Treatment with natural cordyceps sinensis, artificial cordyceps sinensis, traditional Chinese medicine or proprietary Chinese medicine with known renal impairment in recent 2 weeks.
  • 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.
  • 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.
  • History of organ transplant, including kidney transplant.
  • 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.
  • Patients whose disease progresses too rapidly judged by the clinician.
  • Enrolled in other trials in recent 3 months.
  • Patients who are assessed by investigator as unsuitable for inclusion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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