Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath

IgA Nephropathy Clinical Trial

Official title:

Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01879514
• Other study ID #: SHDC12010114
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2013
• Last updated: June 13, 2013
• Start date: January 2010

Study information

• Verified date: June 2013
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: YUEYI DENG, Dr.
• Phone: 64385700
• Email: lhkidney[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.

• Pathology:upon Lee's grade ?

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Chinese Herb Prescription Granule plus prednisone
Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
• Placebo
Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule

Locations

Country	Name	City	State
China	Department of Nephrology,Longhua Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	RenJi Hospital, Shanghai Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate	Evaluation of renal function indicators	12 months	Yes
Secondary	24 hours urine protein	Evaluate the therapeutic effect	12 months	No