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

NCT00004448 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: 199/13463R01DK049368SPNSG-94.052
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Glomerulonephritis

Keywords

IgA glomerulonephritis; rare disease; renal and genitourinary disorders

Outcome Measures

Primary Outcomes (1)

• Time to failure

  Time to failure was defined as the interval until the eGFR fell to \<60% of baseline value.

  Up to 5 years after randomization

Study Arms (3)

Prednisone

EXPERIMENTAL

Tapering regimen of alternate-day prednisone tablets (Deltasone)

Drug: prednisone

omega-3 fatty acids

EXPERIMENTAL

Omega 3 fatty acid Omacor

Drug: omega-3 fatty acids

Placebo

PLACEBO COMPARATOR

Placebo for prednisone or fatty acid

Drug: Placebo

Interventions

omega-3 fatty acids DRUG

Also known as: Omacor

omega-3 fatty acids

prednisone DRUG

Also known as: Deltasone

Prednisone

Placebo DRUG

Placebo

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Southwest Pediatric Nephrology Study Group: collaborator

Study Sites (1)

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Related Publications (3)

• Hogg RJ. A randomized, placebo-controlled, multicenter trial evaluating alternate-day prednisone and fish oil supplements in young patients with immunoglobulin A nephropathy. Scientific Planning Committee of the IgA Nephropathy Study. Am J Kidney Dis. 1995 Nov;26(5):792-6. doi: 10.1016/0272-6386(95)90445-x. No abstract available.

  PMID: 7485134 BACKGROUND

• Hogg RJ, Lee J, Nardelli N, Julian BA, Cattran D, Waldo B, Wyatt R, Jennette JC, Sibley R, Hyland K, Fitzgibbons L, Hirschman G, Donadio JV Jr, Holub BJ; Southwest Pediatric Nephrology Study Group. Clinical trial to evaluate omega-3 fatty acids and alternate day prednisone in patients with IgA nephropathy: report from the Southwest Pediatric Nephrology Study Group. Clin J Am Soc Nephrol. 2006 May;1(3):467-74. doi: 10.2215/CJN.01020905. Epub 2006 Apr 12.

  PMID: 17699247 RESULT

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Rare Diseases; Urogenital Diseases

Interventions

Fatty Acids, Omega-3; Omacor; Prednisone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ronald Hogg

  Southwest Pediatric Nephrology Study Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: November 1, 1997
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: May 4, 2025

Record last verified: 2008-09

Locations

US (1)