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IgA NephropathyPhase 4NCT02231125

Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

A Phase 4 study testing Losartan and Abelmoschus manihot in people with IgA Nephropathy, run by Chen Xiangmei at 88 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 The sponsor has not verified this record for over two years, so it may be out of date.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

-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
IgA Nephropathy
What is being tested?
Losartan and Abelmoschus manihot
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
88 sitesChina
Study dates
Sep 2014to Dec 2017
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosed as chronic nephritic syndrome
  • IgA nephropathy diagnosed by kidney biopsy
  • Aged from 18 to 65 years，male or female
  • Blood pressure of ≤140/90mmHg
  • Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
  • 24-hour proteinuria ranged between 0.5g-3.0g
  • Obtaining the signed informed consent from patients

Who cannot join

  • Secondary IgA nephropathy
  • Be allergic to Huangkui Capsule or Losartan potassium tablet
  • Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
  • Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
  • Blood pressure <90/60mmHg
  • Serum potassium level > 5.5mmol / L
Show all 11Show fewer
  • Serum albumin level <30g / L
  • Lactation, pregnancy or plans pregnancy during the study period
  • Unilateral or bilateral renal artery stenosis
  • Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
  • Participating in another clinical study in the same period

Trial locations and contacts

88 sites in 1 country.

Xiangmei Chen, MD.&Ph.D contact

+86-10-66935462

xmchen301@126.com

Xuefeng Sun, MD.&Ph.D contact

+86-10-66937077

xfssun@126.com

88 sites in 1 country

China88 sites, 16 recruiting

  • Beijing Chao-yang Hospital

    Beijing, Beijing Municipality, 100000

    Completed

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100000

    Wenge Li, +86-13521961922, wenge_lee2002@126.com

    Recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

    Completed

  • Dong Zhi Men Hospital of Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100000

    Completed

  • Guang An Men Hospital China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100000

    Completed

  • PLA Navy General Hospital

    Beijing, Beijing Municipality, 100000

    Completed

  • The Second Artillery General Hospital Of Chinese People's Liberation Army

    Beijing, Beijing Municipality, 100000

    Xiaowen Tu, +86-18910883406, xiaowentu@sohu.com

    Recruiting

  • Jilin Province People's Hospital

    Changchun, Jilin, 130000

    Completed

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

    Completed

  • The Second Hospital Of Jilin University

    Changchun, Jilin, 130000

    Completed

  • The Second Xiang Ya Hospital of Central South University

    Changsha, Hunan, 410000

    Completed

  • The Third Xiang Ya Hospital of Central South University

    Changsha, Hunan, 410000

    Completed

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Completed

  • Affiliated Hospital of Cheng De Medical College

    Chengde, Hebei, 067000

    Completed

  • Hua Xi Hospital of Sichuan University

    Chengdu, Sichuan, 610000

    Completed

  • Da Ping Hospital Of Third Military Medical University

    Chongqing, Chongqing Municipality, 400000

    Completed

  • Yongchuan Hospital Of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Completed

  • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University

    Dalian, Liaoning, 116000

    Completed

  • The First Affiliated Hospital Of Dalian Medical University

    Dalian, Liaoning, 116000

    Completed

  • 421 Hospital of PLA

    Guangzhou, Guangdong, 510000

    Chaoxin Xie, +86-13332889488, xcx421@163.com

    Recruiting

  • Guangdong Province Hospital of Traditional Chinese Medicine(TCM)

    Guangzhou, Guangdong, 510000

    Xusheng Liu, +86-13503078703, liuxu801@126.com

    Recruiting

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541000

    Completed

  • Affiliated Hospital of Guiyang Medical College

    Guiyang, Guizhou, 550000

    Completed

  • The Affiliated Baiyun Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

    Completed

  • Heilongjiang Provincial Academy of Traditional Chinese Medicine

    Haerbin, Heilongjiang, 150000

    Completed

  • The Second Affiliated Hospital of Harbin Medical University

    Haerbin, Heilongjiang, 150000

    Completed

  • Hainan Medical College Affiliated Hospital

    Haikou, Hainan, 570100

    Completed

  • Hainan Provincial Nong Ken Hospital

    Haikou, Hainan, 570100

    Completed

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

    Completed

  • The First Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Completed

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Completed

  • Huang Gang Central Hospital

    Huanggang, Hubei, 438000

    Completed

  • Jinan General Hospital of PLA

    Jinan, Shandong, 250000

    Completed

  • Qi Lu Hospital of Shandong University

    Jinan, Shandong, 250000

    Withdrawn

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272000

    Completed

  • Jining No.1 People's Hospital

    Jining, Shandong, 272000

    Completed

  • First Affiliated Hospital of Liaoning Medical University

    Jinzhou, Liaoning, 121000

    Completed

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Completed

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan, 650000

    Jinwen Wang, +86-13700697545, wjwyayy@163.com

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Tianxi Liu, +86-13919060937, liutianxi@medmail.com.cn

    Recruiting

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

    Jianqin Wang, +86-13919038189, wangjianqin@medmail.com.cn

    Recruiting

  • The First Affiliated Hospital of Henan University of Science And Technology

    Luoyang, Henan, 471000

    Completed

  • Chinese People's Liberation Army No.94 Hospital

    Nanchang, Jiangxi, 330000

    Completed

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330000

    Completed

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330000

    Completed

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330000

    Completed

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, 210000

    Wei Sun, +86-13505199810, jssunwei@163.com

    Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

    Completed

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Completed

  • The First Affiliated Hospital of Guangxi University of Chinese Medicine

    Nanning, Guangxi, 530000

    Completed

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226000

    Yaping Fan, +86-15962998446, fanyp19107@medmail.com.cn

    Recruiting

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337000

    Completed

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 066000

    Completed

  • Chinese People's Liberation Army No.180 Hospital

    Quanzhou, Fujian, 362000

    Li Cheng, +86-13313835596, cl20060606@sina.com

    Recruiting

  • Chang Hai Hospital of the Second Military Medical University

    Shanghai, Shanghai Municipality, 200000

    Completed

  • Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Completed

  • Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Completed

  • People's Liberation Army No.202 Hospital

    Shenyang, Liaoning, 110000

    Completed

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Completed

  • The First Hospital Of China Medical University

    Shenyang, Liaoning, 110000

    Completed

  • The General Hospital Of Shenyang Military Region

    Shenyang, Liaoning, 110000

    Completed

  • The First Hospital of Shi He Zi Medical University

    Shihezi, Xinjiang, 832000

    Xiaoping Yang, +86-13579458071, sbkyxp@163.com

    Recruiting

  • Hebei Province Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei, 050000

    Completed

  • TCM Hospital of Shi Jia Zhuang City

    Shijiazhuang, Hebei, 050000

    Completed

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Shuxia Fu, +86-15803210953, fushuxia99@163.com

    Recruiting

  • Chinese People's Liberation Army No.88 Hospital

    Taian, Shandong, 271000

    Completed

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Completed

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Completed

  • Jiangsu Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

    Completed

  • Taizhou Traditional Chinese Medicine Hospital

    Taizhou, Jiangsu, 225300

    Completed

  • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin Municipality, 300000

    Completed

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

    Completed

  • Tianjin Hospital of ITCWM, Nankai Hospital

    Tianjin, Tianjin Municipality, 300000

    Completed

  • Hubei Provincial Hospital Of TCM

    Wuhan, Hubei, 430000

    Completed

  • Wuhan Integrated TCM & Western Medicine Hospital

    Wuhan, Hubei, 430000

    Completed

  • Zhong Nan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Completed

  • Chinese People's Liberation Army No.174 Hospital

    Xiamen, Fujian, 361000

    Completed

  • Shanxi Provincial People's Hospital

    Xian, Shanxi, 710000

    Completed

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xian, Shanxi, 710000

    Completed

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453000

    Minghao Guo, +86-13937315636, guomh@163.com

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

    Completed

  • Yantai Yu Huang Ding Hospital

    Yantai, Shandong, 264000

    Completed

  • Ningxia Hui Autonomous Region's Hospital

    Yinchuan, Ningxia, 750000

    Yali Zheng, +86-13639505291, 424570556@qq.com

    Recruiting

  • The General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000

    Completed

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277100

    Completed

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

    Fengmin Shao, +86-13607655698, fengminshao@medmail.com.cn

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Completed

  • Affiliated Hospital Of Zun Yi Medical College

    Zunyi, Guizhou, 563000

    Yibin Yang, +86-13765930909, yyb1011@sina.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial

-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.

Read the detailed description

The test has not been completed .

Conditions
IgA Nephropathy
Being tested
Losartan, Abelmoschus manihot
Keywords
Abelmoschus manihot, IgA Nephropathy, proteinuria, efficacy, safety
Medical subject headings
Glomerulonephritis, IGA, Proteinuria

What participants receive

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

  • LosartanDrug

    Also called Cozaar

    Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.

  • Abelmoschus manihotDrug

    Also called Huangkui Capsule

    Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.

Study groups in NCT02231125
Study groupRoleWhat they receive
Abelmoschus manihot (AM)ExperimentalAbelmoschus manihot (AM): Huangkui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.
Receives: Drug: Abelmoschus manihot
LosartanExperimentalLosartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
Receives: Drug: Losartan

What is being measured

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

  1. Change in 24-h proteinuria from baseline after treatment

    Measured: Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Secondary outcomes (2)

  1. Change in serum creatinine from baseline after treatment

    Measured: Baseline(week 0), week 4, week 12, week 24, week 36, week 48

  2. Change in estimated glomerular filtration rate (eGFR) from baseline after treatment

    Measured: Baseline(week 0), week 4, week 12, week 24, week 36, week 48

Timeline

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

  1. First posted4 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJul 2016 (estimated)
  4. Study completionDec 2017 (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
Double blind
Who is masked
Participant, Care provider
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02231125
Sponsor's protocol ID
S2014-039-01
Status last verified
Jul 2016
First submitted
30 Aug 2014
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Zhang L, Li P, Xing CY, Zhao JY, He YN, Wang JQ, Wu XF, Liu ZS, Zhang AP, Lin HL, Ding XQ, Yin AP, Yuan FH, Fu P, Hao L, Miao LN, Xie RJ, Wang R, Zhou CH, Guan GJ, Hu Z, Lin S, Chang M, Zhang M, He LQ, Mei CL, Wang L, Chen X. Efficacy and safety of Abelmoschus manihot for primary glomerular disease: a prospective, multicenter randomized controlled clinical trial. Am J Kidney Dis. 2014 Jul;64(1):57-65. doi: 10.1053/j.ajkd.2014.01.431. Epub 2014 Mar 14.

    PubMed 24631042

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PubMed 38299639

  • Li P, Chen YZ, Lin HL, Ni ZH, Zhan YL, Wang R, Yang HT, Fang JA, Wang NS, Li WG, Sun XF, Chen XM. Abelmoschus manihot - a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):170. doi: 10.1186/s13063-016-1774-6.

    PubMed 28395659

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Losartan and Abelmoschus manihot in people with IgA Nephropathy, run by Chen Xiangmei at 88 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 11 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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 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 Xiangmei Chen, MD.&Ph.D (+86-10-66935462, xmchen301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-h proteinuria from baseline after treatment (time frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48). 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 NCT02231125, which also lists 3 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 6 Jul 2016.

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