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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02662283
Recruitment Status : Unknown
Verified February 2016 by Yanhong Deng, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2016
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
Yanhong Deng, Sun Yat-sen University

Brief Summary:
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.

Condition or disease Intervention/treatment Phase
IGA Nephropathy Drug: Prednisolone Drug: Reh-acteoside Phase 2 Phase 3

Detailed Description:
Reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. It has been reported that acteoside can reduce mesangium lesion of IgA nephrology-model ddy-mice, mainly by reducing the expressing of TGF-β1, reducing proliferation of mesangial cell and glomerular sclerosis. Research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. Thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy. We set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. After followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
Study Start Date : May 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016


Arm Intervention/treatment
Active Comparator: Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
Drug: Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Experimental: Reh-acteoside
Oral take reh-acteoside (0.4g bid) for 8 weeks
Drug: Reh-acteoside
Oral take and reh-acteoside (0.4g bid) for 8 weeks

Experimental: Reh-acteoside+Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks
Drug: Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks

Drug: Reh-acteoside
Oral take and reh-acteoside (0.4g bid) for 8 weeks




Primary Outcome Measures :
  1. Remission of proteinuria (complete or partial) [ Time Frame: up to 8 weeks ]
    Complete remission: UPCR (urinary protein creatinine ratio) <300mg/g, plasma albumin in normal range, and stable serum creatinine level (fluctuation range <15%); Partial remission: UPCR decreases more than 50% from baseline, plasma albumin >30g/L, and stable serum creatinine level (fluctuation range <15%).


Secondary Outcome Measures :
  1. Deterioration of renal function [ Time Frame: up to 8 weeks ]
    evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation

  2. Deacrase of hematuria [ Time Frame: up to 8 weeks ]
    urine RBC decreases more than 50% from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age 14~70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0~3.5g/24h on two successive examinations.

eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign).

Exclusion Criteria:

Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.

Rapidly progressive nephritic syndrome (crescent formation≥50%). Acute renal failure, including rapidly progressive IgAN. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).

Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level.

History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).

Any Active systemic infection or history of serious infection within one month. Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).

Active tuberculosis Malignant hypertension that is difficult to be controlled by oral drugs. Known allergy, contraindication or intolerance to the steroids. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.

Malignant tumors Excessive drinking or drug abuse Mental aberrations Current or recent (within 30 days) exposure to any other investigational drugs.


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): NCT02662283


Contacts
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Contact: Zongpei Jiang, M.D. & Ph.D. 8620-38379727 jx.home@medmail.com.cn

Locations
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China, Guangdong
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Zongpei Jiang, M.D. & Ph.D. The Sixth Affiliated Hospital,Sun Yat-Sen University
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Responsible Party: Yanhong Deng, The Sixth Affiliated Hospital of Sun Yat-Sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02662283    
Other Study ID Numbers: Usix-IgAN-002
First Posted: January 25, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: February 2016
Keywords provided by Yanhong Deng, Sun Yat-sen University:
IGA Nephropathy
proteinurien
Reh-acteoside
Prednisolone
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Acteoside
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protective Agents
Anti-Infective Agents
Antineoplastic Agents, Phytogenic
Antioxidants
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Sequestering Agents
Immunosuppressive Agents
Immunologic Factors