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

March 2, 2015 updated by: Yanhong Deng, Sun Yat-sen University

Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Dongguan, Guangdong, China, 523059
        • Recruiting
        • Department of Nephrology,Dongguan People's Hospital
        • Contact:
        • Principal Investigator:
          • Guohui Liu, MD
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
        • Principal Investigator:
          • Jianbo Liang, MD
        • Contact:
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
        • Principal Investigator:
          • Zongpei Jiang, M.D. & Ph.D.
      • Huizhou, Guangdong, China, 516001
        • Recruiting
        • Department of Nephrology,Huizhou Municipal Central Hospital
        • Contact:
        • Principal Investigator:
          • Weiqiang Zhong, MD
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Department of Nephrology,1st Affiliated Hospital,Shenzhen University
        • Contact:
        • Principal Investigator:
          • Yongcheng He, MD
      • Zhaoqing, Guangdong, China, 526020
        • Recruiting
        • Department of Nephrology,1st People's Hospital of Zhaoqing
        • Contact:
        • Principal Investigator:
          • Jinquan Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission of proteinuria (complete or partial)
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
up to 6 months
The longitudinal decline of kidney function(eGFR)
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 6, 2014

First Posted (Estimate)

June 10, 2014

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Usix-IgAN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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