Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00004448
Other study ID # 199/13463
Secondary ID SPNSG-5RO1DK4936
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated September 8, 2008
Start date November 1997

Study information

Verified date September 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
omega-3 fatty acids

prednisone


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Southwest Pediatric Nephrology Study Group
See also
  Status Clinical Trial Phase
Completed NCT01560052 - Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) N/A
Completed NCT00006137 - Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy N/A
Completed NCT02527902 - Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy N/A
Completed NCT00004305 - Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis N/A
Completed NCT01115426 - Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis Phase 4