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

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ClinicalTrials.gov Identifier: NCT01879514
Recruitment Status : Unknown
Verified June 2013 by yueyi deng, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : June 17, 2013
Last Update Posted : June 17, 2013
Sponsor:
Collaborators:
Shanghai 6th People's Hospital
RenJi Hospital
Information provided by (Responsible Party):
yueyi deng, Shanghai University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Chinese Herb Prescription Granule plus prednisone Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
Study Start Date : January 2010
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Prednisone

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




Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: 12 months ]
    Evaluation of renal function indicators


Secondary Outcome Measures :
  1. 24 hours urine protein [ Time Frame: 12 months ]
    Evaluate the therapeutic effect



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879514


Contacts
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Contact: YUEYI DENG, Dr. 64385700 ext 3222 lhkidney@hotmail.com

Locations
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China
Department of Nephrology,Longhua Hospital Recruiting
Shanghai, China, 200032
Contact: YueYI Deng, Dr.    64385700 ext 3222    lhkidney@hotmail.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Shanghai 6th People's Hospital
RenJi Hospital
Investigators
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Principal Investigator: YueYi Deng, PHD,MD Shanghai University of Traditional Chinese Medicine
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Responsible Party: yueyi deng, Director, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01879514    
Other Study ID Numbers: SHDC12010114
First Posted: June 17, 2013    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013
Keywords provided by yueyi deng, Shanghai University of Traditional Chinese Medicine:
IgA nephropathy
Therapy of Chinese medicine
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents