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Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy

Primary Purpose

IGA Glomerulonephritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
omega-3 fatty acids
prednisone
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for IGA Glomerulonephritis focused on measuring IgA glomerulonephritis, rare disease, renal and genitourinary disorders

Eligibility Criteria

undefined - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed immunoglobulin A nephropathy (IgAN) Patients must have either: - Persistent severe proteinuria alone (urine Pr/Cr ratio at least 1.0) OR - Moderate proteinuria plus renal biopsy changes indicating risk of progression (glomerulosclerosis or proliferation) --Prior/Concurrent Therapy-- Endocrine therapy: At least 1 month since any prior prednisone No more than 3 months of prior prednisone therapy since renal biopsy Other: At least 1 month since any prior immunosuppressive therapy or fish oils No more than 3 months of prior immunosuppressive therapy or fish oil administration since renal biopsy --Patient Characteristics-- Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times ULN No known chronic liver disease Renal: Protein excretion greater than 0.5 g/1.73 m2/24 hours OR Urine protein/creatinine ratio greater than 0.5 on 2 occasions at least 4 weeks apart in the 6 months prior to study Creatinine clearance at least 50 mL/min Other: No systemic lupus erythematosus No Henoch-Schonlein purpura No diabetes mellitus, cataracts, aseptic necrosis of any bone, or other conditions potentially exacerbated by prednisone therapy Not pregnant Adequate contraception required of all fertile patients

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    September 8, 2008
    Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Collaborators
    Southwest Pediatric Nephrology Study Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004448
    Brief Title
    Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1997 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Collaborators
    Southwest Pediatric Nephrology Study Group

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: Evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in slowing or preventing the decline in renal function in children, adolescents, and young adults with moderate to severe immunoglobulin A nephropathy.
    Detailed Description
    PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled, multicenter study. Patients are randomized into one of three treatment arms: placebo, prednisone, or fish oil. The placebo arm is further randomized to receive either fish oil placebo capsules or prednisone placebo tablets. Arm I: Patients receive placebo tablets or capsules for 2 years. Arm II: Patients receive a tapering regimen of prednisone tablets administered every other day for 2 years in the absence of unacceptable toxicity. Arm III: Patients receive fish oil capsules daily for 2 years. Patients may also receive enalapril for hypertension. Patients are followed every 3 months for 3 years after treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IGA Glomerulonephritis
    Keywords
    IgA glomerulonephritis, rare disease, renal and genitourinary disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    123 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    omega-3 fatty acids
    Intervention Type
    Drug
    Intervention Name(s)
    prednisone

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed immunoglobulin A nephropathy (IgAN) Patients must have either: - Persistent severe proteinuria alone (urine Pr/Cr ratio at least 1.0) OR - Moderate proteinuria plus renal biopsy changes indicating risk of progression (glomerulosclerosis or proliferation) --Prior/Concurrent Therapy-- Endocrine therapy: At least 1 month since any prior prednisone No more than 3 months of prior prednisone therapy since renal biopsy Other: At least 1 month since any prior immunosuppressive therapy or fish oils No more than 3 months of prior immunosuppressive therapy or fish oil administration since renal biopsy --Patient Characteristics-- Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times ULN No known chronic liver disease Renal: Protein excretion greater than 0.5 g/1.73 m2/24 hours OR Urine protein/creatinine ratio greater than 0.5 on 2 occasions at least 4 weeks apart in the 6 months prior to study Creatinine clearance at least 50 mL/min Other: No systemic lupus erythematosus No Henoch-Schonlein purpura No diabetes mellitus, cataracts, aseptic necrosis of any bone, or other conditions potentially exacerbated by prednisone therapy Not pregnant Adequate contraception required of all fertile patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Hogg
    Organizational Affiliation
    Southwest Pediatric Nephrology Study Group
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy

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