Nephrotic Syndrome
Conditions
Keywords
Huaiqihuang granule, primary nephrotic syndrome, multisite, prospective, open-label
Brief summary
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
Detailed description
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
Interventions
None listed
Sponsors
Capital Institute of Pediatrics, China
Qidong Gaitianli Medicines Co., Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included; 2. Age from 1 to18; 3. ALT and AST levels do not exceed twice the upper limit of the normal range;; 4. Provision of written informed consent by legal guardians.
Exclusion criteria
1. a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc; 2. with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases; 3. History of diabetes or examinations showed elevated blood glucose levels; 4. Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1; 5. Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ; 6. Patients who are unlikely to adhere to the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of positive urine protein test changing to the negative result | 48 weeks after treatment | Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks. |
| The ratio of positive to negative urine protein | 48 Weeks after treatment | The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks. |
| The decrease of 24-hour urine protein level | 48 Weeks after treatment | Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of blood albumin levels | 48 Weeks after treatment | Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks. |
| Recurrence rate of PNS | 48 Weeks after treatment | The proportion of recurrent subjects to the total number of subjects. |
| Rates of infectious complications of PNS | 48 Weeks after treatment | The proportion of complicated infectious subjects to the total number of subjects. |
Countries
China
Outcome results
None listed