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This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duowell Tab. 40/10mg | Experimental | Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks |
|
| Micardis Tab. 40mg | Active Comparator | Telmisartan 40mg qd for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telmisartan/Rosuvastatin 40/10mg | Drug | Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR) | baseline, week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 24 in UPCR | baseline, week 24 | |
| Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR) | baseline, week 24, week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon-do | South Korea |
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| Telmisartan 40mg | Drug | Telmisartan 40mg qd for 48 weeks |
|
| Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR) |
| baseline, week 24, week 48 |
| Change from baseline to week 48 in UPCR | baseline, week 48 |
| Change from baseline to week 48 in high-sensitivity CRP (hs-CRP) | baseline, week 48 |
| Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR) | baseline, week 48 |
| Change from baseline to week 48 in 24hr urine protein | baseline, week 48 |
| Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks | baseline, week 48 |
| Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1) | baseline, week 48 |
| Change from baseline to week 48 in urinary 8-isoprostane | baseline, week 48 |
| Change from baseline to week 48 in urine nephrin | baseline, week 48 |
| Change from baseline to week 48 in type IV collagen | baseline, week 48 |
| Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks | baseline, week 12, week 24, week 36, week 48 |
| Hallym University Sacred Heart Hospital | Recruiting | Anyang-si | Gyeonggi-do | South Korea |
|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | South Korea |
|
| Korea University Ansan Hospital | Recruiting | Ansan | Gyeonggido | South Korea |
|
| Chonbuk National University Hospital | Recruiting | Jeonju | Jeollabuk-do | South Korea |
|
| Dong-A University Hospital | Not yet recruiting | Busan | South Korea |
| Kyungpook National University Hospital | Recruiting | Daegu | South Korea |
|
| Chungnam National University Hospital | Not yet recruiting | Daejeon | South Korea |
|
| Inje University Ilsan Paik Hospital | Recruiting | Goyang | South Korea |
|
| The Catholic University of Korea Incheon St.Mary's Hospital | Recruiting | Incheon | South Korea |
|
| Presbyterian Medical Center | Not yet recruiting | Jeonju | South Korea |
| Gangnam Severance Hospital | Not yet recruiting | Seoul | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Recruiting | Seoul | South Korea |
|
| korea Universitiy Anam Hospital | Not yet recruiting | Seoul | South Korea |
| KyungHee Universitiy Hospital at Gandong | Recruiting | Seoul | South Korea |
|
| SMG-SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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