Viewing Study NCT06322056



Ignite Creation Date: 2024-05-06 @ 8:18 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06322056
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-03-20
First Post: 2024-03-13

Brief Title: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Sponsor: Yonsei University
Organization: Yonsei University

Study Overview

Official Title: Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EXCELSIOR-CKD
Brief Summary: The purpose of this study is to prevent kidney disease progression in adults with advanced chronic kidney disease estimated glomerular filtration rate eGFR between 15-45 mLmin173 m2 using intensive blood pressure control and intensive lipid management with 2X2 factorial design
Detailed Description: The EXploring approaChEs with Lower targets of blood preSsure and lIpid for impOving Renal outcome in advanced Chronic Kidney Disease EXCELSIOR-CKD strived to enroll about 642 participants aged 19 years with eGFR 15-45 mLmin173 m2 systolic blood pressure SBP 130 mmHg and low-density lipoprotein cholesterol LDL-C 100 mgdL

The EXCELSIOR-CKD study is a 2X2 factorial design with factors consisting of intensive versus standard SBP control 120 vs 140 mmHg and intensive versus standard LDL-C control 70 vs 100 mgdL

The primary hypothesis was that kidney disease progression event rates would be lower in the intensive arms Participants would be recruited at 13 clinics over approximately a 2-year period and are planned to be followed for 3 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None