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GlomerulonephritisPhase 4NCT02063100

Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis

A Phase 4 study testing Shenyankangfu tablets, Losartan potassium 50mg and Shenyankangfu tablets and Losartan potassium 50mg in people with Glomerulonephritis and Proteinuria, run by Chinese PLA General Hospital at 43 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

-Evaluate the efficacy and safety of Shenyankangfu Tablets to control the proteinuria of patients with primary glomerulonephritis compare with Losartan potassium. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Glomerulonephritis, Proteinuria
What is being tested?
Shenyankangfu tablets, Losartan potassium 50mg and Shenyankangfu tablets and Losartan potassium 50mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
43 sitesChina
Study dates
Feb 2014to Jul 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

43 sites in 1 country.

jie wu, doctor contact

+86-010-66937763

wujie301@126.com

jia kou, doctor contact

chinakoujia@163.com

43 sites in 1 country

China43 sites, 43 recruiting

  • National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    jie wu, doctor, wujie301@163.com

    xiangmei chen, doctor

    Recruiting

  • Beijing Friendship,Capital Medical University

    Beijing, Beijing Municipality

    Recruiting

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality

    Recruiting

  • XIyuan Hospital CACMS

    Beijing, Beijing Municipality

    Not yet recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Not yet recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan

    Recruiting

  • General Hospital of Chengdu Military Region of PLA

    Chengdu, Sichuan

    Recruiting

  • Teaching Hospital of Chengdu University of T.C.M

    Chengdu, Sichuan

    Recruiting

  • Daping Hospital,Research Institute of Surgery Third Military Medical University

    Chongqing, Chongqing Municipality

    Recruiting

  • First Affilated Hospital of Dalian Medical University

    Dalian, Liaoning

    Recruiting

  • Fuzhou General Hospital Nanjing Military Command

    Fuzhou, Fujian

    Recruiting

  • Guangdong Province Hospital of Chinese Medical

    Guangzhou, Guangdong

    Recruiting

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

    Recruiting

  • Hangzhou Hospital of Traditional Chinese Medicine

    Hangzhou, Zhejiang

    Recruiting

  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang

    Recruiting

  • Zhejiang Provncial People'S Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang

    Recruiting

  • Shandong Province Hospital

    Jinan, Shandong

    Recruiting

  • Teaching Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong

    Recruiting

  • Jiangxi Provincil People'S Hospital

    Nanchang, Jiangxi

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Recruiting

  • Beidaihe Sanatorium of Beijing Military Mrca

    Qinhuangdao, Hebei

    Recruiting

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality

    Recruiting

  • LONGHUA Hospital Shanghai University of TCM

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University

    Shanghai, Shanghai Municipality

    Recruiting

  • Shugaung Hospital

    Shanghai, Shanghai Municipality

    Recruiting

  • Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Recruiting

  • The Third Hospital of hebei Medical University

    Shijiazhuang, Hebei

    Recruiting

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Recruiting

  • Shanxi Hospital of Integrated Traditional and Westem Medicine

    Taiyuan, Shanxi

    Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

    Recruiting

  • First Teaching Hospital of Tianjin University of TCM

    Tianjin, Tianjin Municipality

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

    Recruiting

  • Shaanxi Traditional Chinese Medicine Hospital

    Xi'an, Shaanxi

    Recruiting

  • Tangdu Hospital

    Xi'an, Shaanxi

    Recruiting

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi'an, Shaanxi

    Recruiting

  • Xijing Hospital

    Xi'an, Shaanxi

    Recruiting

  • 174th hospital of the People's Liberation Army

    Xiamen, Fujian

    Recruiting

  • Henan Provincial People'S Hospital

    Zhengzhou, Henan

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Shenyankangfu Tablets for Primary Glomerulonephritis-a Multicentre, Prospective, Double-blind, Double-dummy, Randomized Controlled Clinical Trial

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

Being tested
Shenyankangfu tablets, Losartan potassium 50mg, Shenyankangfu tablets and Losartan potassium 50mg, Shenyankangfu tablets and Losartan potassium 100mg, Losartan potassium 100mg
Keywords
Glomerulonephritis, proteinuria, shenyankangfu tablets, Losartan Potassium, efficacy, safety
Medical subject headings
Glomerulonephritis, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Shenyankangfu tabletsDrug

    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.

  • Losartan potassium 50mgDrug

    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.

  • Shenyankangfu tablets and Losartan potassium 50mgDrug

    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.

  • Shenyankangfu tablets and Losartan potassium 100mgDrug

    Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.

  • Losartan potassium 100mgDrug

    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 groups in NCT02063100
Study groupRoleWhat they receive
Shenyankangfu tablets and Losartan potassium 100mgExperimentalNot described
Receives: Drug: Shenyankangfu tablets and Losartan potassium 100mg
Shenyankangfu tablets and Losartan potassium 50mgExperimentalNot described
Receives: Drug: Shenyankangfu tablets and Losartan potassium 50mg
Losartan potassium 50mgExperimentalNot described
Receives: Drug: Losartan potassium 50mg
Shenyankangfu tabletsExperimentalNot described
Receives: Drug: Shenyankangfu tablets
Losartan potassium 100mgExperimentalNot described
Receives: Drug: Losartan potassium 100mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes of 24 hours proteinuria after the treatment

    Measured: 0,4,8,12,24,36,48 weeks after the enrollment

Secondary outcomes (3)

  1. changes of serum creatinine after treatment

    Measured: 0,4,8,12,24,36,48 weeks after the enrollment

  2. changes of eGFR after the treatment

    Measured: 0,4,8,12,24,36,48 weeks after the enrollment

  3. changes of Traditional Chinese Medicine syndrome scores after the treatment

    Measured: 0,4,8,12,24,36,48 weeks after the enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionJul 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
720 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02063100
Sponsor's protocol ID
S2013-055-03
Status last verified
Jun 2015
First submitted
12 Feb 2014
Last updated
1 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Wu J, Duan SW, Yang HT, Deng YY, Li W, He YN, Ni ZH, Zhan YL, Lin S, Guo ZY, Zhu J, Fang JA, Liu XS, Wang LH, Wang R, Wang NS, Cheng XH, He LQ, Luo P, Sun SR, Sun JF, Yin AP, Jiang GR, Chen HY, Liu WH, Lin HL, Liang M, Ma L, Chen M, Song LQ, Chen J, Zhu Q, Xing CY, Li Y, Gao JN, Li RS, Li Y, Zhang H, Lu Y, Zhou QL, Fu JZ, He Q, Cai GY, Chen XM. Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial. J Integr Med. 2021 Mar;19(2):111-119. doi: 10.1016/j.joim.2021.01.009. Epub 2021 Jan 30.

    PubMed 33589406

  • 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.

    PubMed 25480673

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Shenyankangfu tablets, Losartan potassium 50mg and Shenyankangfu tablets and Losartan potassium 50mg in people with Glomerulonephritis and Proteinuria, run by Chinese PLA General Hospital at 43 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact jie wu, doctor (+86-010-66937763, wujie301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

changes of 24 hours proteinuria after the treatment (time frame: 0,4,8,12,24,36,48 weeks after the enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02063100, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015.

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