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

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ClinicalTrials.gov Identifier: NCT00004448
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : September 10, 2008
Sponsor:
Collaborator:
Southwest Pediatric Nephrology Study Group
Information provided by:
Office of Rare Diseases (ORD)

October 18, 1999
October 19, 1999
September 10, 2008
November 1997
August 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004448 on ClinicalTrials.gov Archive Site
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Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
IGA Glomerulonephritis
  • Drug: omega-3 fatty acids
  • Drug: prednisone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
Same as current
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August 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
up to 40 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004448
199/13463
SPNSG-5RO1DK49368
SPNSG-94.052
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Southwest Pediatric Nephrology Study Group
Study Chair: Ronald Hogg Southwest Pediatric Nephrology Study Group
Office of Rare Diseases (ORD)
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP