Clinical trial NCT02231125: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy
Official title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IgA Nephropathy
Keywords: Abelmoschus manihot
IgA Nephropathy
proteinuria
efficacy
safety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
First posted: 2014-09-04
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Detailed description: The test has not been completed .

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in 24-h proteinuria from baseline after treatment
timeFrame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Secondary outcomes:
measure: Change in serum creatinine from baseline after treatment
timeFrame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
measure: Change in estimated glomerular filtration rate (eGFR) from baseline after treatment
timeFrame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Dong Zhi Men Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Guang An Men Hospital China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: PLA Navy General Hospital
state: Beijing
city: Beijing
country: China
facility: The Second Artillery General Hospital Of Chinese People's Liberation Army
state: Beijing
city: Chongqing
country: China
facility: Da Ping Hospital Of Third Military Medical University
state: Chongqing
city: Chongqing
country: China
facility: Yongchuan Hospital Of Chongqing Medical University
state: Chongqing
city: Quanzhou
country: China
facility: Chinese People's Liberation Army No.180 Hospital
state: Fujian
city: Xiamen
country: China
facility: Chinese People's Liberation Army No.174 Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: 421 Hospital of PLA
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Traditional Chinese Medicine(TCM)
state: Guangdong
city: Guilin
country: China
facility: Affiliated Hospital of Guilin Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi University of Chinese Medicine
state: Guangxi
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Guiyang
country: China
facility: The Affiliated Baiyun Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital Of Zun Yi Medical College
state: Guizhou
city: Haikou
country: China
facility: Hainan Medical College Affiliated Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial Nong Ken Hospital
state: Hainan
city: Chengde
country: China
facility: Affiliated Hospital of Cheng De Medical College
state: Hebei
city: Qinhuangdao
country: China
facility: First Hospital of Qinhuangdao
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Province Hospital of Traditional Chinese Medicine
state: Hebei
city: Shijiazhuang
country: China
facility: TCM Hospital of Shi Jia Zhuang City
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Haerbin
country: China
facility: Heilongjiang Provincial Academy of Traditional Chinese Medicine
state: Heilongjiang
city: Haerbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science And Technology
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Huanggang
country: China
facility: Huang Gang Central Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Provincial Hospital Of TCM
state: Hubei
city: Wuhan
country: China
facility: Wuhan Integrated TCM & Western Medicine Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhong Nan Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiang Ya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Third Xiang Ya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Taizhou
country: China
facility: Jiangsu Taizhou People's Hospital
state: Jiangsu
city: Taizhou
country: China
facility: Taizhou Traditional Chinese Medicine Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Chinese People's Liberation Army No.94 Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital Of Nanchang University
state: Jiangxi
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital Of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital Of Dalian Medical University
state: Liaoning
city: Jinzhou
country: China
facility: First Affiliated Hospital of Liaoning Medical University
state: Liaoning
city: Shenyang
country: China
facility: People's Liberation Army No.202 Hospital
state: Liaoning
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital Of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: The General Hospital Of Shenyang Military Region
state: Liaoning
city: Yinchuan
country: China
facility: Ningxia Hui Autonomous Region's Hospital
state: Ningxia
city: Yinchuan
country: China
facility: The General Hospital of Ningxia Medical University
state: Ningxia
city: Jinan
country: China
facility: Jinan General Hospital of PLA
state: Shandong
city: Jinan
country: China
facility: Qi Lu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Jining
country: China
facility: Jining No.1 People's Hospital
state: Shandong
city: Taian
country: China
facility: Chinese People's Liberation Army No.88 Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Yu Huang Ding Hospital
state: Shandong
city: Zaozhuang
country: China
facility: Zaozhuang Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Chang Hai Hospital of the Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Xian
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
city: Xian
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Chengdu
country: China
facility: Hua Xi Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Hospital of ITCWM, Nankai Hospital
state: Tianjin
city: Shihezi
country: China
facility: The First Hospital of Shi He Zi Medical University
state: Xinjiang
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: Yan'an Hospital of Kunming City
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
affiliation: Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital
name: Xiangmei Chen, MD.& Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.