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Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

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ClinicalTrials.gov Identifier: NCT02063100
Recruitment Status : Unknown
Verified June 2015 by Chen Xiangmei, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 14, 2014
Last Update Posted : July 1, 2015
Sponsor:
Collaborator:
Tianjin TongRenTang Group Co., Ltd.
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE February 12, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date July 1, 2015
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
changes of 24 hours proteinuria after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2014)
  • changes of serum creatinine after treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
  • changes of eGFR after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
  • changes of Traditional Chinese Medicine syndrome scores after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
  • changes of serum creatinine after treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment albumin ]
  • changes of eGFR after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
  • changes of Traditional Chinese Medicine syndrome scores after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis
Official Title  ICMJE Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis—a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial
Brief Summary -Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glomerulonephritis
  • Proteinuria
Intervention  ICMJE
  • Drug: Shenyankangfu tablets
    Shenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
  • Drug: Losartan potassium 50mg
    Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab,po, 1/day, all drugs and placebo are taken for 48 weeks.
  • Drug: Shenyankangfu tablets and Losartan potassium 50mg
    Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab, po, 1/day, all drugs and placebo are taken for 48 weeks.
  • Drug: Shenyankangfu tablets and Losartan potassium 100mg
    Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
  • Drug: Losartan potassium 100mg
    Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
Study Arms  ICMJE
  • Experimental: Shenyankangfu tablets and Losartan potassium 100mg
    Intervention: Drug: Shenyankangfu tablets and Losartan potassium 100mg
  • Experimental: Shenyankangfu tablets and Losartan potassium 50mg
    Intervention: Drug: Shenyankangfu tablets and Losartan potassium 50mg
  • Experimental: Losartan potassium 50mg
    Intervention: Drug: Losartan potassium 50mg
  • Experimental: Shenyankangfu tablets
    Intervention: Drug: Shenyankangfu tablets
  • Experimental: Losartan potassium 100mg
    Intervention: Drug: Losartan potassium 100mg
Publications * Kou J, Wu J, Yang HT, He YN, Fang JA, Deng YY, Xie YS, Nie LF, Lin HL, Cai GY, Chen XM. Efficacy and safety of Shenyankangfu tablets for primary glomerulonephritis: study protocol for a randomized controlled trial. Trials. 2014 Dec 5;15:479. doi: 10.1186/1745-6215-15-479.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
720
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion

  • Diagnosed with primary glomerulonephritis
  • Aged from 18 to 70 years,male or female
  • Blood pressure can be controlled ≤140/90mmHg
  • GFR≥45ml/min/1.73㎡
  • 0.5g≤24 hours proteinuria≤3.0g
  • Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
  • Obtain the agreement of patients or their guardians, and signed informed consent file

Exclusion Criteria:

  • secondary nephropathy
  • Take the glucocorticoid,immunosuppressants and Tripterygium drug in the last 12 months
  • Take other Chinese patent medicine and decoction which can reduce proteinuria in the last 2 weeks
  • Take renin-angiotensin system blockers in last 4 weeks
  • Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
  • Pregnant or lactating women
  • Allergic predisposition or known to be allergic to the drug composition
  • Blood presser <90/60mmHg
  • With unilateral or bilateral renal artery stenosis
  • With mental disorders and poor compliance
  • Be suspected or confirmed with alcohol, drug abuse history
  • Be participating in another clinical study at the same period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063100
Other Study ID Numbers  ICMJE S2013-055-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chen Xiangmei, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Tianjin TongRenTang Group Co., Ltd.
Investigators  ICMJE
Principal Investigator: xiangmei chen, Doctor State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP