Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pronova BioPharma ASA | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy
In the current clinical study, attempts are made to assess the safety and efficacy of omega-3 fatty acids by comparing between omega-3 fatty acids and the placebo in Korean patients with IgA nephropathy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omacor | Experimental |
| |
| Placebo Omacor | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega-3 fatty acid ethylester90 | Drug | Dosage form :1g soft capsule Dosage : two capsules, twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of number of patients that 50% or more increase in SCr after 42 months | 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months | 42 months | |
| Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile | 42 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suhnggwon Kim, Professor | Seoul National University Hospital | Study Chair |
| Byung-Joo Park, MD,PhD,FISPE | Seoul National University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | Kyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Hospital |
Not provided
| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C405603 | Omacor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Seoul |
| 110-740 |
| South Korea |
| Kyhung Hee University medical center | Seoul | 130-702 | South Korea |
| Samsumg Medical Center | Seoul | 135-710 | South Korea |
| Kangnam St. May's Hospital | Seoul | 137-701 | South Korea |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |