Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Chinese PLA General Hospital
Sponsor:
Collaborators:
Tianjin TongRenTang Group Co., Ltd.
Beijing Friendship Hospital
XIyuan Hospital CACMS
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin Medical University General Hospital
Longhua Hospital
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT02063100
First received: February 12, 2014
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium.


Condition Intervention Phase
Glomerulonephritis
Proteinuria
Drug: Shenyankangfu tablets
Drug: Losartan potassium 50mg
Drug: Shenyankangfu tablets and Losartan potassium 50mg
Drug: Shenyankangfu tablets and Losartan potassium 100mg
Drug: Losartan potassium 100mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis—a Multicentre, Prospective, Randomized, Double-blind, Double-dummy Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • changes of 24 hours proteinuria after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes of serum creatinine after treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment albumin ] [ Designated as safety issue: No ]
  • changes of eGFR after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ] [ Designated as safety issue: No ]
  • changes of Traditional Chinese Medicine syndrome scores after the treatment [ Time Frame: 0,4,8,12,24,36,48 weeks after the enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: February 2014
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shenyankangfu tablets and Losartan potassium 100mg 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.
Experimental: Shenyankangfu tablets and Losartan potassium 50mg 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.
Experimental: Losartan potassium 50mg 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.
Experimental: Shenyankangfu tablets 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.
Experimental: Losartan potassium 100mg 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 triptolide medications 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063100

Contacts
Contact: jie wu, doctor +86-010-66937763 wujie301@126.com
Contact: jia kou, doctor chinakoujia@163.com

  Show 43 Study Locations
Sponsors and Collaborators
Chinese PLA General Hospital
Tianjin TongRenTang Group Co., Ltd.
Beijing Friendship Hospital
XIyuan Hospital CACMS
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin Medical University General Hospital
Longhua Hospital
Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University
Shanghai Jiao Tong University School of Medicine
ShuGuang Hospital
Investigators
Principal Investigator: xiangmei chen, Doctor State Key Laboratory of Kidney Diseases,Chinese PLA General Hospital
  More Information

No publications provided

Responsible Party: Chen Xiangmei, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02063100     History of Changes
Other Study ID Numbers: S2013-055-03
Study First Received: February 12, 2014
Last Updated: May 14, 2014
Health Authority: China: Ministry of Science and Technology

Keywords provided by Chinese PLA General Hospital:
Glomerulonephritis
proteinuria
shenyankangfu tablets
Losartan Potassium
efficacy
safety

Additional relevant MeSH terms:
Urination Disorders
Glomerulonephritis
Proteinuria
Nephritis
Kidney Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014