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

NCT04349683 | Unknown Phase 4

• 1 other identifier: NE-JSB-01
• Study Type: interventional
• Target: 332
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of surem creatinine and 24-hour urine protein

  Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Change of urinary protein/creatinine ratio (PCR)

  Baseline to 12 weeks, 24 weeks, 36 weeks, 48 weeks

• Change of hs-CRP

  Baseline to 24 weeks, 48 weeks

• Change of 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

  48 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

basic treatment combined with Jinshuibao

Drug: Jinshuibao

Control group

PLACEBO COMPARATOR

basic treatment and placebo

Drug: Placebo

Interventions

Jinshuibao DRUG

6 capsules at a time, 3 times a day (tid).

Also known as: basic treatment

Experimental group

Placebo DRUG

6 capsules at a time, 3 times a day (tid).

Also known as: basic treatment

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead
• Shanghai 6th People's Hospital: collaborator

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Glomerulonephritis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nephritis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 16, 2020
• Study Start: April 30, 2020
• Primary Completion: August 30, 2021
• Study Completion: October 30, 2021
• Last Updated: April 20, 2020

Record last verified: 2020-04