Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004448
Status:
COMPLETED
Last Update Posted:
2008-09-10
First Post:
1999-10-18
Brief Title:
Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPNSG-5RO1DK49368 | None | None | None |
| SPNSG-94052 | None | None | None |