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| Name | Class |
|---|---|
| Chong Kun Dang Pharmaceutical Corp. | INDUSTRY |
| Kyung Hee University Hospital at Gangdong | OTHER |
| Kyungpook National University Hospital | OTHER |
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The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.
The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.
The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.
The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil | Experimental | MYREPT® capsule(CKDpharm, KOREA) and corticosteroid |
|
| Conservative treatment | Active Comparator | maintain conservative treatment (ACE inhibitor or ARB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate (complete / partial) | up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate (complete / partial) | at 12 weeks, at 24 weeks, at 36 weeks | |
| eGFR(estimated glomerular filtration rate) by MDRD(modification of diet in renal disease) | at 24 weeks, at 36 weeks, at 48 weeks |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EUNJU JUNG | Contact | 82-10-5414-7760 | oakly74@nate.com | |
| JONGHYUK LEE | Contact | 82-10-5599-1199 | leejongh@ckdpharm.com |
| Name | Affiliation | Role |
|---|---|---|
| BEOMSUK KIM | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D000072700 | Conservative Treatment |
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Pusan National University Yangsan Hospital |
| OTHER |
| Inje University | OTHER |
| Seoul St. Mary's Hospital | OTHER |
| Chonbuk National University Hospital | OTHER |
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| ACE inhibitor | Drug | maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization |
|
|
| Corticosteroid | Drug | combination with Mycophenolate Mofetil |
|
|
| ARB | Drug | maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization |
|
|
| The incidence of renal replacement therapy | renal replacement therapy; dialysis, new transplant | up to 48 weeks |
| The average time to occurrence of renal replacement therapy | renal replacement therapy; dialysis, new transplant | up to 48 weeks |
| 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 |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D013812 | Therapeutics |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |