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Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
This study has been completed.
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Southwest Pediatric Nephrology Study Group
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004448
  Purpose

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.


Condition Intervention Phase
IGA Glomerulonephritis
Drug: omega-3 fatty acids
Drug: prednisone
Phase II

MedlinePlus related topics: Dietary Supplements
Drug Information available for: Prednisone Immunoglobulins Globulin, Immune Fish oil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 123
Study Start Date: November 1997
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004448

Sponsors and Collaborators
Southwest Pediatric Nephrology Study Group
Investigators
Study Chair: Ronald Hogg Southwest Pediatric Nephrology Study Group
  More Information

Study ID Numbers: 199/13463, SPNSG-5RO1DK49368, SPNSG-94.052
Study First Received: October 18, 1999
Last Updated: September 8, 2008
ClinicalTrials.gov Identifier: NCT00004448  
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
IgA glomerulonephritis
rare disease
renal and genitourinary disorders

Study placed in the following topic categories:
Prednisone
Immunoglobulin A
Antibodies
Glomerulonephritis
Autoimmune Diseases
Urologic Diseases
Nephritis
Berger disease
Rare Diseases
Glomerulonephritis, IGA
Kidney Diseases
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009