Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318474
Status:
TERMINATED
Last Update Posted:
2016-03-07
First Post:
2006-04-24
Brief Title:
Mycophenolate Mofetil MMF in Patients With IgA Nephropathy
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
Status:
TERMINATED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB recommended stopping the trial because of lack of effect
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
IgA nephropathy IgAN is the most common type of glomerulonephritis worldwide 15-40 of individuals diagnosed with IgAN including children will eventually progress to chronic renal insufficiency CRI and end stage renal disease ESRD The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated and continue to be treated with angiotensin converting enzyme inhibitors ACEi and fish oil supplements FOS
Detailed Description:
A multi-center randomized controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil MMF will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated and continue to be treated with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF Data for this outcome will be examined every six months and at the end of 2 years of study Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine UPrCr ratio 24-hour urine protein excretion rate and estimated glomerular filtration rate GFR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 48977 | OTHER | None | None |
| Canadian Control 076948 | OTHER | Bureau of Pharmaceutical Assessment - Canada | None |