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Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT02231125
Recruitment Status : Unknown
Verified July 2016 by Chen Xiangmei, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : September 4, 2014
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Information provided by (Responsible Party):
Chen Xiangmei, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: Losartan Drug: Abelmoschus manihot Phase 4

Detailed Description:
The test has not been completed .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy: a Multicentre, Double-blind, Double-dummy, Randomized Controlled Trial
Study Start Date : September 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Abelmoschus manihot (AM)
Abelmoschus 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.
Drug: 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.
Other Name: Huangkui Capsule

Experimental: Losartan
Losartan potassium (Hangzhou MSD Pharmaceutical Co., Ltd.), 100 mg × 7 capsules/box.
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.
Other Name: Cozaar




Primary Outcome Measures :
  1. Change in 24-h proteinuria from baseline after treatment [ Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48 ]

Secondary Outcome Measures :
  1. Change in serum creatinine from baseline after treatment [ Time Frame: 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 [ Time Frame: Baseline(week 0), week 4, week 12, week 24, week 36, week 48 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231125


Contacts
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Contact: Xiangmei Chen, MD.&Ph.D +86-10-66935462 xmchen301@126.com
Contact: Xuefeng Sun, MD.&Ph.D +86-10-66937077 xfssun@126.com

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Sponsors and Collaborators
Chen Xiangmei
Jiangsu Suzhong Pharmaceutical Group Co., Ltd.
Investigators
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Principal Investigator: Xiangmei Chen, MD.& Ph.D Department of Nephrology,State Key Laboratory of Kidney Disease,National Clinical Research Center for Kidney Disease, Chinese PLA General Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chen Xiangmei, professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02231125     History of Changes
Other Study ID Numbers: S2014-039-01
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chen Xiangmei, Chinese PLA General Hospital:
Abelmoschus manihot
IgA Nephropathy
proteinuria
efficacy
safety
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action