Exploring Approaches With Lower Targets of Blood Pressure and Lipid for Improving Renal Outcome in Advanced Chronic Kidney Disease

NCT06322056 | Recruiting

• 1 other identifier: 4-2023-1654
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

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 mL/min/1.73 m2) using intensive blood pressure control and intensive lipid management with 2X2 factorial design.

Conditions

Chronic Kidney Diseases; Hypertension; Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Renal composite outcome

  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

  up to 3 years

Secondary Outcomes (3)

• Individual components of renal composite outcome

  up to 3 years

• eGFR slopes

  up to 3 years

• Cardiovascular composite outcome

  up to 3 years

Study Arms (4)

Intensive SBP control and Intensive LDL-C control

ACTIVE COMPARATOR

Targeting SBP \<120 mmHg and targeting LDL-C \<70 mg/dL

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

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

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

Drug: Standard control of SBP and standard control of LDL-C

Interventions

Intensive control of SBP and intensive control of LDL-C DRUG

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 SBP control and Intensive LDL-C control

Intensive control of SBP and standard control of LDL-C DRUG

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.

Intensive SBP control and Standard LDL-C control

Standard control of SBP and intensive control of LDL-C DRUG

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 SBP control and Intensive LDL-C control

Standard control of SBP and standard control of LDL-C DRUG

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.

Standard SBP control and Standard LDL-C control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mmHg on 0 or 1 medication
• mmHg on upto 2 medications
• mmHg on more than 3 medications
• LDL-C ≥100 mg/dL

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 40478754 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Seung Hyeok Han

CONTACT

82-2-2228-1984; hansh@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)