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

Primary Purpose

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

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Jinshuibao

Placebo

About this trial

This is an interventional treatment trial for Chronic Kidney Disease Stage 3B

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

basic treatment combined with Jinshuibao

basic treatment and placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of surem creatinine and 24-hour urine protein

Surem creatinine (Scr) will be tested by a central laboratory

Change of urinary protein/creatinine ratio (PCR)

Change from baseline in PCR

Change of hs-CRP

Change from baseline in hs-CRP

Change of TNF-α, IL-1β, and IL-6

Change from baseline in TNF-α, IL-1β, and IL-6

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

Patients' Quality of life

Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version)

Number of rehospitalizations

Number of rehospitalizations during the follow-up period

Full Information

NCT ID

NCT04349683

First Posted

April 15, 2020

Last Updated

April 16, 2020

Sponsor

Jemincare

Collaborators

Shanghai 6th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04349683

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 30, 2020 (Anticipated)

Primary Completion Date

August 30, 2021 (Anticipated)

Study Completion Date

October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jemincare

Collaborators

Shanghai 6th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

basic treatment combined with Jinshuibao

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

basic treatment and placebo

Intervention Type

Drug

Intervention Name(s)

Jinshuibao

Other Intervention Name(s)

basic treatment

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

basic treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of estimated glomerular filtration rate

Description

Estimated Glomerular Filtration Rate (eGFR) will be calculated according to Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) creatinine equation

Time Frame

Baseline to 48 weeks

Secondary Outcome Measure Information:

Title

Change of surem creatinine and 24-hour urine protein

Description

Surem creatinine (Scr) will be tested by a central laboratory

Time Frame

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

Title

Change of urinary protein/creatinine ratio (PCR)

Description

Change from baseline in PCR

Time Frame

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

Title

Change of hs-CRP

Description

Change from baseline in hs-CRP

Time Frame

Baseline to 24 weeks, 48 weeks

Title

Change of TNF-α, IL-1β, and IL-6

Description

Change from baseline in TNF-α, IL-1β, and IL-6

Time Frame

Baseline to 24 weeks and 48 weeks

Title

Time to decline of 50% in eGFR or development of ESRD, and incidence of decline of 50% in eGFR or development of ESRD

Description

End stage renal disease (ESRD）is defined by the need for long-term dialysis or renal transplantation, or eGFR<15ml/min

Time Frame

48 weeks

Title

Patients' Quality of life

Description

Patients' Quality of life will be accessed by KDQOL-36 (Chinese Version)

Time Frame

Baseline to 24 weeks and 48 weeks

Title

Number of rehospitalizations

Description

Number of rehospitalizations during the follow-up period

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

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