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| Name | Class |
|---|---|
| The Catholic University of Korea | OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Kyungpook National University Hospital | OTHER |
| Korea University Guro Hospital |
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Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis worldwide. IgAN is progressive, particularly when patients have a significant proteinuria (proteinuria >1g/g creatinine), impaired kidney function, or elevated blood pressure. In 10 years, nearly 20-40% of these IgAN patients progress to end-stage renal disease (ESRD). Early IgAN is tentatively defined when proteinuria is insignificant and kidney function and blood pressure are normal. Patients with early IgAN rarely progress to ESRD. However, 30-40% of patients with early IgAN ultimately developed a significant proteinuria and hypertension in 10 years. Therefore, earlier intervention may be needed if it can prevent the development of a significant proteinuria and hypertension. Since angiotensin ll receptor blocker (ARB) is drug of choice in reducing proteinuria and controlling blood pressure, the investigators hypothesized that early introduction of ARB may be beneficial in preventing the significant proteinuria development in early IgAN patients. To prove the hypothesis, the investigators plan the current interventional study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Losartan group | Experimental | Losartan 50 mg daily |
|
| Placebo group | Placebo Comparator | Placebo 1 pill daily which has same size, color and taste with losartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan group | Drug | Losartan 50 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Significant proteinuria rate | Random urine protein-to-creatinine ratio >= 1g/g creatinine | 144 weeks after study started |
| Measure | Description | Time Frame |
|---|---|---|
| Proteinuria remission rate | Random urine protein-to-creatinine ratio < 0.20 g/g creatinine | 48 weeks, 96 weeks, and 144 weeks after study started |
| Impaired kidney function rate | estimated glomerular filtration rate decline >= 40% from the baseline value |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Ryeol Ryu, Professor | Contact | 82-2-2650-2507 | drryu@ewha.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Ryeol Ryu, Professor | Ewha Womans University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23331443 | Background | Li PK, Kwan BC, Chow KM, Leung CB, Szeto CC. Treatment of early immunoglobulin A nephropathy by angiotensin-converting enzyme inhibitor. Am J Med. 2013 Feb;126(2):162-8. doi: 10.1016/j.amjmed.2012.06.028. | |
| 26874511 | Background | Jo YI, Na HY, Moon JY, Han SW, Yang DH, Lee SH, Park HC, Choi HY, Lim SD, Kie JH, Lee YK, Shin SK. Effect of low-dose valsartan on proteinuria in normotensive immunoglobulin A nephropathy with minimal proteinuria: a randomized trial. Korean J Intern Med. 2016 Mar;31(2):335-43. doi: 10.3904/kjim.2014.266. Epub 2016 Feb 15. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2017 | Nov 28, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D011507 | Proteinuria |
| D018450 | Disease Progression |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019808 | Losartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| Seoul National University Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
| Pusan National University Yangsan Hospital | OTHER |
| Severance Hospital | OTHER |
| Eulji General Hospital | OTHER |
| National Health Insurance Service Ilsan Hospital | OTHER |
| Chonnam National University Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
| Kangdong Sacred Heart Hospital | OTHER |
| Hallym University Medical Center | OTHER |
| Gangnam Severance Hospital | OTHER |
The investigators will test the effect of ARB to prevent the development of significant proteinuria, defined as random urine protein-to-creatinine ratio of >1g/g creatinine. In this study, the investigators choose losartan as a testing ARB. The investigators will compare the rate of significant proteinuria development between 2 arms, namely losartan group and placebo group after 144 weeks' treatment.
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| Placebo group | Drug | Placebo 1 pill daily |
|
|
| 48 weeks, 96 weeks, and 144 weeks after study started |
| Hypertension development rate | Systolic blood pressure >= 140 or diastolic blood pressure >= 90 | 48 weeks, 96 weeks, and 144 weeks after study started |
| 9631840 | Background | Nieuwhof C, Kruytzer M, Frederiks P, van Breda Vriesman PJ. Chronicity index and mesangial IgG deposition are risk factors for hypertension and renal failure in early IgA nephropathy. Am J Kidney Dis. 1998 Jun;31(6):962-70. doi: 10.1053/ajkd.1998.v31.pm9631840. |
| 11007671 | Background | Lai FM, Szeto CC, Choi PC, Li PK, Chan AW, Tang NL, Lui SF, Wang AY, To KF. Characterization of early IgA nephropathy. Am J Kidney Dis. 2000 Oct;36(4):703-8. doi: 10.1053/ajkd.2000.17614. |
| 11331053 | Background | Szeto CC, Lai FM, To KF, Wong TY, Chow KM, Choi PC, Lui SF, Li PK. The natural history of immunoglobulin a nephropathy among patients with hematuria and minimal proteinuria. Am J Med. 2001 Apr 15;110(6):434-7. doi: 10.1016/s0002-9343(01)00659-3. |
| 17596724 | Background | Shen P, He L, Li Y, Wang Y, Chan M. Natural history and prognostic factors of IgA nephropathy presented with isolated microscopic hematuria in Chinese patients. Nephron Clin Pract. 2007;106(4):c157-61. doi: 10.1159/000104426. Epub 2007 Jun 26. |
| 24946688 | Background | Lee H, Hwang JH, Paik JH, Ryu HJ, Kim DK, Chin HJ, Oh YK, Joo KW, Lim CS, Kim YS, Lee JP. Long-term prognosis of clinically early IgA nephropathy is not always favorable. BMC Nephrol. 2014 Jun 19;15:94. doi: 10.1186/1471-2369-15-94. |
| 38299639 | Derived | 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |