Chronic Kidney DiseasesEXCELSIOR-CKDNCT06322056
Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
A study of Chronic Kidney Diseases and Hypertension, run by Yonsei University at 1 site in South Korea.
Trial 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 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Dyslipidemias
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 642 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2024to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of all of followings
- At least 19 years old
- Evidence of CKD defined at least 3 months before and at the time of screening visit with CKD-EPI eGFR ≥15 to <45 mL/min/1.73 m2
- SBP of
- 130-180 mmHg on 0 or 1 medication
- 130-170 mmHg on upto 2 medications
- 130-160 mmHg on more than 3 medications
- LDL-C ≥100 mg/dL
Who cannot join
- Any of followings
- Resistant hypertension or poorly controlled hypertension
- Failure to achieve SBP of <140 mmHg despite using 4 or more antihypertensive medications including diuretics
- Known secondary cause of hypertension
- History of renal devervation procedure
- Glomerulonephritis requiring immunosuppresive agents
Show all 27Show fewer
- Autosomal dominant polycystic kidney disease receiving tolvaptan
- CKD-EPI < 15 mL/min/1.73 m2 or receiving kidney replacement therapy
- Familial hypercholesterolemia
- Cardiovascular event or precedure (as defined as myocardial infarction, unstable angina, coronary revascularization, or stroke) within last 3 months or planning to cardiovascular procedure upcoming 3 months at the time of screening visit
- Symptomatic heart failure within 6 months of left ventricular ejection fraction <45%
- A medical condition likely to limit survival to less thant 3 years
- Diagnosis of malignancy within the last 5 years or undergoing chemotherepy or radiotherapy
- Any organ transplant
- Advanced cirrhosis (Child-Pugh class B or C) or abnormal liver function test (alanine transaminase or aspartate transaminase ≥1.5 X upper normal limit)
- Evidence of active inflammatory muscle disease (polymyositis or dermatomyositis) or creatine kinase elevation (≥3 X upper normal limit)
- History of adverse reaction to HMG-CoA reductase inhibitors or ezetimibe
- Using any drugs as followings:
- Nicotinic acid
- Macrolide antibiotics
- Systemic imidazole or triazole antifungal agent
- Protease inhibitor
- Nefazodone
- Immunosuppressive agents (glucocorticoid [equivalent to prednisone 10 mg/day over 4 weeks], cyclosporin, mycofenolate, azathioprine, methotrexate, cyclophosphamide, or rituximab)
- Pregnancy or trying to become pregnant
- Diabetes mellitus, type I
- Diabetes mellitus, type II with HbA1c ≥10.0%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Seung Hyeok Han, MD, Ph.D, 82-2-2228-1984, hansh@yuhs.ac
About this study
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 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.
Read the 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 mL/min/1.73 m2, systolic blood pressure (SBP) ≥130 mmHg, and low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL.
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 mg/dL).
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.
- Conditions
- Chronic Kidney Diseases, Hypertension, Dyslipidemias
- Being tested
- Intensive control of SBP and intensive control of LDL-C, Intensive control of SBP and standard control of LDL-C, Standard control of SBP and intensive control of LDL-C, Standard control of SBP and standard control of LDL-C
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive control of SBP and intensive control of LDL-CDrug
Eligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 70 mg/dL.
Intensive control of SBP and standard control of LDL-CDrug
Eligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 100 mg/dL.
Standard control of SBP and intensive control of LDL-CDrug
Eligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 70 mg/dL.
Standard control of SBP and standard control of LDL-CDrug
Eligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 100 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| Intensive SBP control and Intensive LDL-C control | Active comparator | Targeting SBP <120 mmHg and targeting LDL-C <70 mg/dL Receives: Drug: Intensive control of SBP and intensive control of LDL-C |
| Intensive SBP control and Standard LDL-C control | Active comparator | Targeting SBP <120 mmHg and targeting LDL-C <100 mg/dL Receives: Drug: Intensive control of SBP and standard control of LDL-C |
| Standard SBP control and Intensive LDL-C control | Active comparator | Targeting SBP <140 mmHg and targeting LDL-C <70 mg/dL Receives: Drug: Standard control of SBP and intensive control of LDL-C |
| Standard SBP control and Standard LDL-C control | Active comparator | Targeting SBP <140 mmHg and targeting LDL-C <100 mg/dL Receives: Drug: Standard control of SBP and standard control of LDL-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal composite outcome
Renal composite outcome would be defined as one of followings:
- A sustained decline in eGFR of 40%,
- Initiation of kidney replacement therapy (dialysis or kidney transplantation),
- A sustained eGFR <10 mL/min/1.73 m2, or
- Death from renal causes
Measured: up to 3 years
Secondary outcomes (3)
Individual components of renal composite outcome
- A sustained decline in eGFR of 40%
- Initiation of kidney replacement therapy (dialysis or kidney transplantation),
- A sustained eGFR <10 mL/min/1.73 m2
- Death from renal causes
- Rate of change of eGFR during chronic phase I (12 week to 3 year)
- Rate of change of eGFR during chronic phase II (24 week to 3 year)
- Rate of change of eGFR during study period (0 week to 3 year)
- Cardiovascular composite outcome (defined as one of followings):
- Death from cardiovascular causes,
- Non-fatal myocardial infarction,
- Non-fatal stroke (ischemic or hemorrhagic),
- Hospitalization for heart failure, or
- Revascularization (coronary, carotid, or peripheral artery)
Measured: up to 3 years
eGFR slopes
- A sustained decline in eGFR of 40%
- Initiation of kidney replacement therapy (dialysis or kidney transplantation),
- A sustained eGFR <10 mL/min/1.73 m2
- Death from renal causes
- Rate of change of eGFR during chronic phase I (12 week to 3 year)
- Rate of change of eGFR during chronic phase II (24 week to 3 year)
- Rate of change of eGFR during study period (0 week to 3 year)
- Cardiovascular composite outcome (defined as one of followings):
- Death from cardiovascular causes,
- Non-fatal myocardial infarction,
- Non-fatal stroke (ischemic or hemorrhagic),
- Hospitalization for heart failure, or
- Revascularization (coronary, carotid, or peripheral artery)
Measured: up to 3 years
Cardiovascular composite outcome
- A sustained decline in eGFR of 40%
- Initiation of kidney replacement therapy (dialysis or kidney transplantation),
- A sustained eGFR <10 mL/min/1.73 m2
- Death from renal causes
- Rate of change of eGFR during chronic phase I (12 week to 3 year)
- Rate of change of eGFR during chronic phase II (24 week to 3 year)
- Rate of change of eGFR during study period (0 week to 3 year)
- Cardiovascular composite outcome (defined as one of followings):
- Death from cardiovascular causes,
- Non-fatal myocardial infarction,
- Non-fatal stroke (ischemic or hemorrhagic),
- Hospitalization for heart failure, or
- Revascularization (coronary, carotid, or peripheral artery)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 May 2024
- Primary completion31 May 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 642 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322056
- Sponsor's protocol ID
- 4-2023-1654
- Acronym
- EXCELSIOR-CKD
- Status last verified
- Dec 2024
- First submitted
- 13 Mar 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park CH, Kim HW, Park JT, Chang TI, Yoo TH, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; on the behalf of CRIC Study and KNOW-CKD Investigators. BP and Kidney Disease Progression in Advanced CKD: Findings from the Chronic Renal Insufficiency Cohort and KoreaN Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2025 Jun 6;20(9):1179-1189. doi: 10.2215/CJN.0000000760.
PubMed 40478754
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06322056
- Acronym / sponsor ID
- EXCELSIOR-CKD / 4-2023-1654
- Conditions
- Chronic Kidney Diseases, Hypertension, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 642 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 mL/min/1.73 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 mL/min/1.73 m2, systolic blood pressure (SBP) ≥130 mmHg, and low-density lipoprotein cholesterol (LDL-C) ≥100 mg/dL.
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 mg/dL).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intensive SBP control and Intensive LDL-C control | Active comparator | Drug: Intensive control of SBP and intensive control of LDL-CTargeting SBP <120 mmHg and targeting LDL-C <70 mg/dL |
| Intensive SBP control and Standard LDL-C control | Active comparator | Drug: Intensive control of SBP and standard control of LDL-CTargeting SBP <120 mmHg and targeting LDL-C <100 mg/dL |
| Standard SBP control and Intensive LDL-C control | Active comparator | Drug: Standard control of SBP and intensive control of LDL-CTargeting SBP <140 mmHg and targeting LDL-C <70 mg/dL |
| Standard SBP control and Standard LDL-C control | Active comparator | Drug: Standard control of SBP and standard control of LDL-CTargeting SBP <140 mmHg and targeting LDL-C <100 mg/dL |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Fulfillment of all of followings
Key exclusion criteria (27 listed)
- Any of followings
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive control of SBP and intensive control of LDL-CEligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 70 mg/dL. | Drug | Intensive SBP control and Intensive LDL-C control |
| Intensive control of SBP and standard control of LDL-CEligible participants would be assigned to a SBP target of less than 120 mmHg and a LDL-C target of less than 100 mg/dL. | Drug | Intensive SBP control and Standard LDL-C control |
| Standard control of SBP and intensive control of LDL-CEligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 70 mg/dL. | Drug | Standard SBP control and Intensive LDL-C control |
| Standard control of SBP and standard control of LDL-CEligible participants would be assigned to a SBP target of less than 140 mmHg and a LDL-C target of less than 100 mg/dL. | Drug | Standard SBP control and Standard LDL-C control |
Primary outcome
Renal composite outcome
Time frame: up to 3 years
Renal composite outcome would be defined as one of followings: 1. A sustained decline in eGFR of 40%, 2. Initiation of kidney replacement therapy (dialysis or kidney transplantation), 3. A sustained eGFR <10 mL/min/1.73 m2, or 4. Death from renal causes
3 secondary outcomes
Individual components of renal composite outcome
Time frame: up to 3 years
eGFR slopes
Time frame: up to 3 years
Cardiovascular composite outcome
Time frame: up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Derived from this study: PubMed 40478754Park CH, Kim HW, Park JT, Chang TI, Yoo TH, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; on the behalf of CRIC Study and KNOW-CKD Investigators. BP and Kidney Disease Progression in Advanced CKD: Findings from the Chronic Renal Insufficiency Cohort and KoreaN Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2025 Jun 6;20(9):1179-1189. doi: 10.2215/CJN.0000000760.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Kidney Diseases and Hypertension, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Hyeok Han (82-2-2228-1984, hansh@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal composite outcome (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.