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

June 13, 2013 updated by: yueyi deng, Shanghai University of Traditional Chinese Medicine
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Department of Nephrology,Longhua Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Group
Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks
Drug: Chinese Herb Prescription Granule plus prednisone
Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
Placebo Comparator: Placebo
Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks
Drug: Placebo
Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate
Time Frame: 12 months
Evaluation of renal function indicators
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 hours urine protein
Time Frame: 12 months
Evaluate the therapeutic effect
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Collaborators

RenJi Hospital
Shanghai 6th People's Hospital

Investigators

  • Principal Investigator: YueYi Deng, PHD,MD, Shanghai University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 13, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHDC12010114

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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