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Integrative Medicine of IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02712697
Recruitment Status : Unknown
Verified November 2015 by Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Not yet recruiting
First Posted : March 18, 2016
Last Update Posted : March 18, 2016
Sponsor:
Collaborators:
RenJi Hospital
Ruijin Hospital
Shanghai 6th People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
Information provided by (Responsible Party):
Shanghai University of Traditional Chinese Medicine

Brief Summary:
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.

Condition or disease Intervention/treatment Phase
Primary IgA Nephropathy Drug: WM (Shentong Granules) Drug: Hormone (prednisone) Not Applicable

Detailed Description:
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: WM Group
Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
Drug: WM (Shentong Granules)
Shentong Granules with Prednisone
Other Name: Shentong Granules

Drug: Hormone (prednisone)
Oral prednisone
Other Name: prednisone

Placebo Comparator: Hormone Group
Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months
Drug: Hormone (prednisone)
Oral prednisone
Other Name: prednisone




Primary Outcome Measures :
  1. Glomerular filtration rate [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]

Secondary Outcome Measures :
  1. 24-hour urinary protein excretion [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
  2. serum creatinine [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]
  3. serum Lipid [ Time Frame: Half-yearly ]
  4. TCM syndrome score [ Time Frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
  2. TCM is liver kidney yin deficiency syndrome;
  3. age 18-70 years old, sex, nationality is not limited;
  4. CKD phase 2-4 (89 ml/min>eGFR(EPI Formula)>15ml/min/1.73m2);
  5. 24 hour urinary protein≥1g.

Exclusion Criteria:

  1. It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
  2. It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
  3. Acute or progressive glomerulonephritis patients;
  4. Severe complications threat to life, such as severe infection;
  5. Active hepatitis B and liver function test sustained abnormal;
  6. Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
  7. Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
  8. Gravid or lactation woman;
  9. Other clinical trials are being studied;
  10. Merger with other serious disease and dysfunction of the organ.

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): NCT02712697


Contacts
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Contact: Yueyi Deng, MD. +86-021-64385700-3226 dengyueyi@medmail.com.cn
Contact: Wanjia Chen, MS. +86-021-64385700-3222 wdgzkj@sina.com

Locations
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China
Department of Nephrology,Longhua Hospital
Shanghai, China, 200032
Contact: YueYI Deng, Dr.    64385700 ext 3222    lhkidney@hotmail.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
RenJi Hospital
Ruijin Hospital
Shanghai 6th People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Fudan University
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Responsible Party: Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02712697    
Other Study ID Numbers: ZY3- CCCX-2-1002
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: March 18, 2016
Last Verified: November 2015
Keywords provided by Shanghai University of Traditional Chinese Medicine:
liver-kidney yin deficiency syndrome
primary severe IgA nephropathy
Lee's grade Ⅲ
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisone
Hormones
Anti-Inflammatory Agents
Glucocorticoids
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents