UnknownPhase 4

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

332 participantsStarted 2020-04-30

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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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.

What they're measuring

Change of estimated glomerular filtration rate

Timeframe: Baseline to 48 weeks

Trial details

NCT IDNCT04349683

SponsorJemincare

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-30

View on ClinicalTrials.gov More Chronic Kidney Disease Stage 3B trials