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Clinical Trial Details

Trial ID: L0387
Source ID: NCT03550859
Associated Drug: Telmisartan/Rosuvastatin 40/10mg
Title: HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Proteinuria
Interventions: DRUG: Telmisartan/Rosuvastatin 40/10mg|DRUG: Telmisartan 40mg
Outcome Measures: Primary: Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR), baseline, week 48 | Secondary: 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|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
Sponsor/Collaborators: Sponsor: Yuhan Corporation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 374
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2018-06-05
Completion Date: 2021-12
Results First Posted:
Last Update Posted: 2020-12-14
Locations: Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, Korea, Republic of|Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea, Republic of|Korea University Ansan Hospital, Ansan, Gyeonggido, Korea, Republic of|Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of|Dong-A University Hospital, Busan, Korea, Republic of|Kyungpook National University Hospital, Daegu, Korea, Republic of|Chungnam National University Hospital, Daejeon, Korea, Republic of|Inje University Ilsan Paik Hospital, Goyang, Korea, Republic of|The Catholic University of Korea Incheon St.Mary's Hospital, Incheon, Korea, Republic of|Presbyterian Medical Center, Jeonju, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of|korea Universitiy Anam Hospital, Seoul, Korea, Republic of|KyungHee Universitiy Hospital at Gandong, Seoul, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03550859