Clinical trial NCT01879514: Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
Official title: Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
Therapy of Chinese medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai 6th People's Hospital
name: RenJi Hospital
First posted: 2013-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.


Eligibility criteria: Inclusion Criteria:

* Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
* Pathology:upon Lee's grade Ⅲ
* Age :18-60 years old.
* Gender and nationality are not limited
* Chronic Kidney Disease(CKD) Stage 3:（59 ml/min\>GFR\>30ml/min/1.73m2）
* 24-hour urine protein:≥1.0g.Informed consent

Exclusion Criteria:

* Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
* Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
* Patients suffering from acute or rapidly progressive glomerulonephritis
* Patients continue with active hepatitis B and abnormal liver function tests transaminase
* Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
* Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L
* Pregnancy or breast-feeding women
* Receiving other clinical trials
* Associated with other serious diseases and organ dysfunction
* Combined life-threatening complications such as severe infection

Primary outcomes:
measure: Glomerular filtration rate
timeFrame: 12 months
Secondary outcomes:
measure: 24 hours urine protein
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Nephrology,Longhua Hospital
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: YueYi Deng, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: