ITMCTR2100004925
Recruiting
Phase 1
Preclinical study on the expanded indications of Fuzheng Huayu Tablets against renal fibrosis
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine0 sitesTBD
ConditionsPrimary glomerulonephritis (CKD Stage 3)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary glomerulonephritis (CKD Stage 3)
- Sponsor
- Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Aged 18 to 70 years, gender: male or female;
- •2\.In line with the Western medical diagnostic criteria for chronic kidney disease,patients with CKD grade 3(eGFR\>30\-59 ml / min / 1\.73m^2\) according to the K / DOQI recommended grading criteria for renal impairment and who had renal biopsy pathological data of glomerulonephritis (CKD grade 3\).The EPI formula as follows: eGFR\=ax(Scr/b)^Cx0\.993^Age(a values were taken separately according to gender as follows, male \= 141 female \= 144; The b values are taken as follows depending on gender, male \= 0\.9 female \= 0\.7; The c value takes the following values based on age and size of serum creatinine, respectively, for men: serum creatinine \<\= 0\.7 mg / dl \= \-0\.411 serum creatinine \> 0\.7 mg / dl \= \-1\.209 for women: serum creatinine \<\= 0\.7 mg / dl \= \-0\.329 serum creatinine \> 0\.7 mg / dl \= \-1\.209\);
- •3\.Blood pressure control \<\= 140 / 90 mmHg with SBP \>\= 100 mmHg and DBP \>\= 60 mmHg;
- •4\.Severe infections, water, electrolyte and acid\-base balance disorders are effectively controlled, and serum potassium is within the normal range;
- •5\.Testing after 2 weeks of the lead\-in period was eligible for patients with GFR: 30\-59 ml / min / 1\.73m^2 and BP \<\= 140 / 90 mmHg(patients are taking calcium antagonists, diuretics, and sympathetic nerve suppression do not need to enter the lead\-in period);
- •6\.Volunteered to participate in the clinical study and agreed to sign an informed consent form.
Exclusion Criteria
- •1\.Patients with severe primary diseases including heart, brain, liver and hematopoietic system need prompt treatment;
- •2\.24\-hour urine protein quantification \<0\.3g; 24\-hour urine protein quantification\>2\.0 g;
- •3\.Hb \<\=100g/L;
- •4\.Patients have had hemodialysis or peritoneal dialysis in the past;
- •5\.Secondary renal diseases such as diabetic nephropathy or multiple myeloma should be excluded;
- •6\.Patients were participating in other clinical trials of drugs or had participated in other clinical trials within 3 months or had used western glucocorticoids, immunosuppressive agents, Tripterygium wilfordii preparations;
- •7\.Patients had taken other traditional Chinese medicines for nearly 2 weeks, which might affect the judgment of efficacy, can only be selected after two weeks of elution;
- •8\.If the patients have used angiotensin\-converting enzyme inhibitors, or angiotensin receptor antagonists, they need to wash out 2 weeks before for being selected;
- •9\.Pregnant or lactating women;
- •10\.Allergic to drugs and their ingredients involved in this study;
Outcomes
Primary Outcomes
Not specified
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