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Due to challenges in recruitment and visits during COVID
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The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive home blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.
The transition from advanced chronic kidney disease (CKD), when estimated glomerular filtration rate (eGFR) is <=30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a vulnerable period, when multiple physiologic and psychosocial changes occur as patients prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled trial to test the safety and feasibility of studying strict versus usual BP control in a population of patients with advanced CKD (eGFR <=30 mL/min/1.73m2), including those with diabetes. For this pilot study, we will randomize 120 patients with advanced CKD who have elevated BP to either a home SBP target of <120 mm Hg (intervention group) versus usual care (130-140 mmHg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict SBP Target | Experimental | Target Systolic Home Blood Pressure <120 mm Hg |
|
| Usual SBP Target | No Intervention | Target Systolic Home Blood Pressure 130-140 mm Hg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strict blood pressure control | Other | Systolic Blood Pressure Target < 120 mm Hg (measured at home) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achieved Clinic Systolic Blood Pressure | Achieved clinic SBP at month 12 | At month 12 |
| Difference in Clinic SBP Between the Two Arms | Incorporating achieved mean SBP data between months 4-12 | Months 4-12 |
| Hyperkalemia, Syncope, Falls, ESKD | Potassium >=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization | Months 0-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Screening to Enrollment Ratio | This is the number of potential participants screened as eligible to the number who agree to enroll | From baseline entry through the end of Year 3 of study |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Achieved SBP | Clinic | Between month 4 after baseline and year 4 of study |
| Hyperkalemia, Syncope, Falls, ESKD | Potassium >=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation |
Inclusion Criteria:
Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have
Exclusion criteria
Those who:
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Hsu, MD MAS | University of California, San Francisco | Principal Investigator |
| Elaine Ku, MD MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39427725 | Derived | Ku E, Copeland TP, McCulloch CE, Seth D, Carlos CA, Cho K, Malkina A, Lo LJ, Hsu RK. Intensive Home Blood Pressure Lowering in Patients With Advanced CKD. Am J Kidney Dis. 2025 Mar;85(3):320-328. doi: 10.1053/j.ajkd.2024.08.010. Epub 2024 Oct 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual SBP Target | Target Systolic Home Blood Pressure 130-140 mm Hg |
| FG001 | Strict SBP Target | Target Systolic Home Blood Pressure <120 mm Hg Strict blood pressure control: Systolic Blood Pressure Target < 120 mm Hg (measured at home) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual SBP Target | Target Systolic Home Blood Pressure 130-140 mm Hg |
| BG001 | Strict SBP Target | Target Systolic Home Blood Pressure <120 mm Hg Strict blood pressure control: Systolic Blood Pressure Target < 120 mm Hg (measured at home) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Achieved Clinic Systolic Blood Pressure | Achieved clinic SBP at month 12 | Posted | Mean | Standard Deviation | mmHg | At month 12 |
|
|
Between baseline and year 4 of study
The study team collected adverse event information from the participants weekly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strict SBP Target | Target Systolic Home Blood Pressure <120 mm Hg Strict blood pressure control: Systolic Blood Pressure Target < 120 mm Hg (measured at home) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause hospitalization | Investigations | hospitalization | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury or ER visit | Renal and urinary disorders | hospitalization | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elaine Ku | University of California, San Francisco Division of Nephrology | 415-502-7760 | elaine.ku@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2025 | Feb 13, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 13, 2025 | Feb 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Between month 4 after baseline and year 4 of study |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Clinic systolic blood pressure | Median | Inter-Quartile Range | mmHg |
|
| Clinic diastolic blood pressure | Median | Inter-Quartile Range | mmHg |
|
| Diabetes | Count of Participants | Participants |
|
| Baseline eGFR | Median | Inter-Quartile Range | mL/min/1.73 m2 |
|
| Urine protein/creatinine ratio | Median | Inter-Quartile Range | g/g |
|
| History of heart failure | Count of Participants | Participants |
|
| History of acute coronary syndrome | Count of Participants | Participants |
|
| History of Smoking | Count of Participants | Participants |
|
| Insurance | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Difference in Clinic SBP Between the Two Arms | Incorporating achieved mean SBP data between months 4-12 | Difference is measured between months 4-12 | Posted | Mean | 95% Confidence Interval | mmHg | Months 4-12 |
|
|
|
|
| Primary | Hyperkalemia, Syncope, Falls, ESKD | Potassium >=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization | Posted | Count of Participants | Participants | Months 0-12 |
|
|
|
| Secondary | Screening to Enrollment Ratio | This is the number of potential participants screened as eligible to the number who agree to enroll | Number of participants screened to enroll 1 participant | Posted | Number | participants | From baseline entry through the end of Year 3 of study |
|
|
|
| Other Pre-specified | Difference in Achieved SBP | Clinic | Posted | Mean | 95% Confidence Interval | mmHg | Between month 4 after baseline and year 4 of study |
|
|
|
|
| Other Pre-specified | Hyperkalemia, Syncope, Falls, ESKD | Potassium >=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation | Posted | Count of Participants | Participants | Between month 4 after baseline and year 4 of study |
|
|
|
| 5 |
| 66 |
| 30 |
| 66 |
| 18 |
| 66 |
| EG001 | Usual SBP Target | Target Systolic Home Blood Pressure 130-140 mm Hg | 2 | 42 | 22 | 42 | 10 | 42 |
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| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Falls |
|
| Dialysis or (re)-transplant |
|
| Falls |
|
| Dialysis or (re)-transplant |
|