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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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15 February 2016 |
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Main ID: |
NCT02662283 |
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Date of registration:
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20/01/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy
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Scientific title:
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Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy —— A Prospective, Randomized, Controlled, Multi-Center Clinical Trial |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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75 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02662283 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Zongpei Jiang, M.D. & Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Sixth Affiliated Hospital,Sun Yat-Sen University |
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Name:
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Zongpei Jiang, M.D. & Ph.D. |
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Address:
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Telephone:
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8620-38379727 |
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Email:
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jx.home@medmail.com.cn |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
14 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IGA Nephropathy
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Intervention(s)
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Drug: Reh-acteoside
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Drug: Prednisolone
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Primary Outcome(s)
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Remission of proteinuria (complete or partial)
[Time Frame: up to 8 weeks]
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Secondary Outcome(s)
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Deterioration of renal function
[Time Frame: up to 8 weeks]
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Deacrase of hematuria
[Time Frame: up to 8 weeks]
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Secondary ID(s)
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Usix-IgAN-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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