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A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

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: NCT02160132
Recruitment Status : Unknown
Verified March 2015 by Yanhong Deng, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 10, 2014
Last Update Posted : March 3, 2015
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 steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.

Condition or disease Intervention/treatment Phase
Glomerulonephritis, IGA Peripapillary Crescent Necrosis Steroid Nephropathy Drug: Methylprednisolone(intravenously in the 1st-2nd-3rd month ) Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month) Phase 2

Detailed Description:
It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
Study Start Date : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: A 1-2-3Group
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Drug: Methylprednisolone(intravenously in the 1st-2nd-3rd month )
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Active Comparator: B 1-3-5Group
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month)
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.




Primary Outcome Measures :
  1. Remission of proteinuria (complete or partial) [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Deterioration of renal function (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). [ Time Frame: up to 6 months ]
  2. The longitudinal decline of kidney function(eGFR) [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 14~65 years, regardless of gender
  • Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.
  • Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.
  • eGFR ≥ 50 ml/min/1.73 m2
  • Willingness to sign an informed consent.

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.
  • Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
  • Date of renal biopsy exceeds more than 30 days.
  • Cirrhosis, chronic active liver disease.
  • 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): NCT02160132


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,Dongguan People's Hospital Recruiting
Dongguan, Guangdong, China, 523059
Contact: Guohui Liu, MD    86769-28637333    liuguohui5@126.com   
Principal Investigator: Guohui Liu, MD         
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Jianbo Liang, MD    8620-34152282    boliangjian@tom.com   
Principal Investigator: Jianbo Liang, MD         
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Zongpei Jiang, M.D. & Ph.D.    8620-38379727    jx.home@medmail.com.cn   
Principal Investigator: Zongpei Jiang, M.D. & Ph.D.         
Department of Nephrology,Huizhou Municipal Central Hospital Recruiting
Huizhou, Guangdong, China, 516001
Contact: Weiqiang Zhong, MD    86752-2288288    13809669766@126.com   
Principal Investigator: Weiqiang Zhong, MD         
Department of Nephrology,1st Affiliated Hospital,Shenzhen University Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Yongcheng He, MD    86755-83366388    heyongcheng@medmail.com.cn   
Principal Investigator: Yongcheng He, MD         
Department of Nephrology,1st People's Hospital of Zhaoqing Recruiting
Zhaoqing, Guangdong, China, 526020
Contact: Jinquan Wu, MD    86758-2832139    zqwujq@163.com   
Principal Investigator: Jinquan Wu, MD         
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: NCT02160132    
Other Study ID Numbers: Usix-IgAN-001
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: March 3, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Glomerulonephritis
Necrosis
Urologic Diseases
Pathologic Processes
Nephritis
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents