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

Primary Purpose

IgA Nephropathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese Herb Prescription Granule plus prednisone
Placebo
Sponsored by
Shanghai University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, Therapy of Chinese medicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Nephrology,Longhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination Group

Placebo

Arm Description

Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks

Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks

Outcomes

Primary Outcome Measures

Glomerular filtration rate
Evaluation of renal function indicators

Secondary Outcome Measures

24 hours urine protein
Evaluate the therapeutic effect

Full Information

First Posted
March 25, 2013
Last Updated
June 13, 2013
Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai 6th People's Hospital, RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01879514
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai University of Traditional Chinese Medicine
Collaborators
Shanghai 6th People's Hospital, RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy, Therapy of Chinese medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination Group
Arm Type
Experimental
Arm Description
Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks
Intervention Type
Drug
Intervention Name(s)
Chinese Herb Prescription Granule plus prednisone
Intervention Description
Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule
Primary Outcome Measure Information:
Title
Glomerular filtration rate
Description
Evaluation of renal function indicators
Time Frame
12 months
Secondary Outcome Measure Information:
Title
24 hours urine protein
Description
Evaluate the therapeutic effect
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YUEYI DENG, Dr.
Phone
64385700
Ext
3222
Email
lhkidney@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YueYi Deng, PHD,MD
Organizational Affiliation
Shanghai University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology,Longhua Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YueYI Deng, Dr.
Phone
64385700
Ext
3222
Email
lhkidney@hotmail.com

12. IPD Sharing Statement

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

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