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ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT

Primary Purpose

Glomerulonephritis, IGA

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prednisone + Inhibace/Cozaar
Inhibace/Cozaar
Sponsored by
Peking University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis, IGA

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. underwent renal biopsy within 1 year before start fo trial;
  2. 24 hour urinary protein excretion ranged between 1 to 7 g/d;
  3. eGFR, evaluated by MDRD formula, should be higher than 30 ml/min

Exclusion Criteria:

  1. crescentic glomerulonephritis;
  2. steroid therapy subjected within 1 year before trial;
  3. malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents;
  4. urinary protein excretion decrease below 1 g/l after run-in period;
  5. Myocardial infarction or cerebrovascular accident in 6 months preceding the trial;
  6. renovascular disease;
  7. diabetes mellitus;
  8. Malignancy, severe liver disease, refractory infection;
  9. peptic ulcer in active disease phase;
  10. pregnancy;
  11. other contraindication to the use of ACEi/ ARB or corticosteroid;
  12. alcohol abuse or drug addiction

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Serum creatinine
    24 hour urinary protein excretion

    Secondary Outcome Measures

    Urinalysis
    serum urea
    serum albumin

    Full Information

    First Posted
    September 19, 2006
    Last Updated
    September 21, 2006
    Sponsor
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00378443
    Brief Title
    ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    June 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Peking University

    4. Oversight

    5. Study Description

    Brief Summary
    IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. Both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.
    Detailed Description
    IgA nephropathy( IgAN) is the most common primary glomerulonephritis worldwide. Since the etiology of the disease is not clearly understood, no specific therapeutic strategies was defined for IgAN. In the many studies on the treatment of IgAN, both ACEi/ARB and steroid was found to be effective in slowing the rate of disease progression, but the use of steroid was restricted because of its side effects, and ACEi/ARB was considered to be the first line therapy. However, there is no evidence from RCT on the question of whether combined use of steroid with ACEi/ARB can bring more benefit to IgAN patients than ACEi/ARB alone. We therefore undertook a randomized, multicenter study to investigate the efficacy and safety profile of combined use of ACEi/ARB plus steroid compared with ACEi/ARB alone in the treatment of patients with IgAN.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glomerulonephritis, IGA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    prednisone + Inhibace/Cozaar
    Intervention Type
    Drug
    Intervention Name(s)
    Inhibace/Cozaar
    Primary Outcome Measure Information:
    Title
    Serum creatinine
    Title
    24 hour urinary protein excretion
    Secondary Outcome Measure Information:
    Title
    Urinalysis
    Title
    serum urea
    Title
    serum albumin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: underwent renal biopsy within 1 year before start fo trial; 24 hour urinary protein excretion ranged between 1 to 7 g/d; eGFR, evaluated by MDRD formula, should be higher than 30 ml/min Exclusion Criteria: crescentic glomerulonephritis; steroid therapy subjected within 1 year before trial; malignant hypertension(DBP> 130 mmHg and/or SBP> 220mmHg), resistant to anti-hypertensive agents; urinary protein excretion decrease below 1 g/l after run-in period; Myocardial infarction or cerebrovascular accident in 6 months preceding the trial; renovascular disease; diabetes mellitus; Malignancy, severe liver disease, refractory infection; peptic ulcer in active disease phase; pregnancy; other contraindication to the use of ACEi/ ARB or corticosteroid; alcohol abuse or drug addiction
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hong Zhang, MD
    Organizational Affiliation
    Renal Division, Peking University First Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18930568
    Citation
    Lv J, Zhang H, Chen Y, Li G, Jiang L, Singh AK, Wang H. Combination therapy of prednisone and ACE inhibitor versus ACE-inhibitor therapy alone in patients with IgA nephropathy: a randomized controlled trial. Am J Kidney Dis. 2009 Jan;53(1):26-32. doi: 10.1053/j.ajkd.2008.07.029. Epub 2008 Oct 19.
    Results Reference
    derived

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    ACEi/ARB Alone Versus ACEi/ARB Plus Steroids in the Treatment of Primary IgA Nephropathy, a RCT

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