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Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy Clinical research trials and Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy. Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy clinical trial. Subjects often receive the most expert healthcare possible for their Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy  Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy
Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy
For Condition: IGA Glomerulonephritis
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , Southwest Pediatric Nephrology Study Group
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: /40 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 123
Location and Contact Information:
Overall Study Official:
RonaldHogg, Study Chair, Southwest Pediatric Nephrology Study Group
Additional Information:
Study ID Numbers: 199/13463; SPNSG-5RO1DK49368,SPNSG-94.052
Study Start Date: November 1997
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004448
Other Iga Glomerulonephritis Studies:
1. Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis
2. Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy
3. Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy
Related Studies:
Other IGA Glomerulonephritis Clinical Trials
Other Clinical Trials
Other Clinical Trials
Alternate Day Prednisone or Daily Fish Oil Supplements in Patients with Immunoglobulin A Nephropathy
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