Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02231125
• Other study ID #: S2014-039-01
• Status: Recruiting
• Phase: Phase 4
• First received: August 30, 2014
• Last updated: July 4, 2016
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Chinese PLA General Hospital
• Contact: Xiangmei Chen, MD.&Ph.D
• Phone: +86-10-66935462
• Email: xmchen301[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and TechnologyChina: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

Description:

The test has not been completed .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Losartan
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 manihot
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.

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Dong Zhi Men Hospital of Beijing University of Chinese Medicine	Beijing	Beijing
China	Guang An Men Hospital China Academy of Chinese Medical Sciences	Beijing	Beijing
China	PLA Navy General Hospital	Beijing	Beijing
China	The Second Artillery General Hospital Of Chinese People's Liberation Army	Beijing	Beijing
China	Jilin Province People's Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital Of Jilin University	Changchun	Jilin
China	The Second Xiang Ya Hospital of Central South University	Changsha	Hunan
China	The Third Xiang Ya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Affiliated Hospital of Cheng De Medical College	Chengde	Hebei
China	Hua Xi Hospital of Sichuan University	Chengdu	Sichuan
China	Da Ping Hospital Of Third Military Medical University	Chongqing	Chongqing
China	Yongchuan Hospital Of Chongqing Medical University	Chongqing	Chongqing
China	Dalian Municipal Central Hospital Affiliated Of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital Of Dalian Medical University	Dalian	Liaoning
China	421 Hospital of PLA	Guangzhou	Guangdong
China	Guangdong Province Hospital of Traditional Chinese Medicine(TCM)	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Affiliated Hospital of Guiyang Medical College	Guiyang	Guizhou
China	The Affiliated Baiyun Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Heilongjiang Provincial Academy of Traditional Chinese Medicine	Haerbin	Heilongjiang
China	The Second Affiliated Hospital of Harbin Medical University	Haerbin	Heilongjiang
China	Hainan Medical College Affiliated Hospital	Haikou	Hainan
China	Hainan Provincial Nong Ken Hospital	Haikou	Hainan
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Hospital of Anhui Medical University	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Huang Gang Central Hospital	Huanggang	Hubei
China	Jinan General Hospital of PLA	Jinan	Shandong
China	Qi Lu Hospital of Shandong University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining	Shandong
China	Jining No.1 People's Hospital	Jining	Shandong
China	First Affiliated Hospital of Liaoning Medical University	Jinzhou	Liaoning
China	The Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Yan'an Hospital of Kunming City	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The Second Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science And Technology	Luoyang	Henan
China	Chinese People's Liberation Army No.94 Hospital	Nanchang	Jiangxi
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital Of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi University of Chinese Medicine	Nanning	Guangxi
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Jiangxi Pingxiang People's Hospital	Pingxiang	Jiangxi
China	First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Chinese People's Liberation Army No.180 Hospital	Quanzhou	Fujian
China	Chang Hai Hospital of the Second Military Medical University	Shanghai	Shanghai
China	Ren Ji Hospital of Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital Affiliated Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	People's Liberation Army No.202 Hospital	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital Of China Medical University	Shenyang	Liaoning
China	The General Hospital Of Shenyang Military Region	Shenyang	Liaoning
China	The First Hospital of Shi He Zi Medical University	Shihezi	Xinjiang
China	Hebei Province Hospital of Traditional Chinese Medicine	Shijiazhuang	Hebei
China	TCM Hospital of Shi Jia Zhuang City	Shijiazhuang	Hebei
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Chinese People's Liberation Army No.88 Hospital	Taian	Shandong
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Jiangsu Taizhou People's Hospital	Taizhou	Jiangsu
China	Taizhou Traditional Chinese Medicine Hospital	Taizhou	Jiangsu
China	First Teaching Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Hospital of ITCWM, Nankai Hospital	Tianjin	Tianjin
China	Hubei Provincial Hospital Of TCM	Wuhan	Hubei
China	Wuhan Integrated TCM & Western Medicine Hospital	Wuhan	Hubei
China	Zhong Nan Hospital of Wuhan University	Wuhan	Hubei
China	Chinese People's Liberation Army No.174 Hospital	Xiamen	Fujian
China	Shanxi Provincial People's Hospital	Xian	Shanxi
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xian	Shanxi
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Yantai Yu Huang Ding Hospital	Yantai	Shandong
China	Ningxia Hui Autonomous Region's Hospital	Yinchuan	Ningxia
China	The General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital Of Zun Yi Medical College	Zunyi	Guizhou

Sponsors (2)

Lead Sponsor	Collaborator
Chen Xiangmei	Jiangsu Suzhong Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-h proteinuria from baseline after treatment		Baseline(week 0), week 4, week 12, week 24, week 36, week 48	No
Secondary	Change in serum creatinine from baseline after treatment		Baseline(week 0), week 4, week 12, week 24, week 36, week 48	No
Secondary	Change in estimated glomerular filtration rate (eGFR) from baseline after treatment		Baseline(week 0), week 4, week 12, week 24, week 36, week 48	No