Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD

NCT02975505 | Terminated Results DMC

• 1 other identifier: 16-20978
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease; Bloodpressure; Hypertension

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Screening to Enrollment Ratio

  From baseline entry through the end of Year 3 of study

Other Outcomes (2)

• Difference in Achieved SBP

  Between month 4 after baseline and year 4 of study

• Hyperkalemia, Syncope, Falls, ESKD

  Between month 4 after baseline and year 4 of study

Study Arms (2)

Strict SBP Target

EXPERIMENTAL

Target Systolic Home Blood Pressure \<120 mm Hg

Other: Strict blood pressure control

Usual SBP Target

NO INTERVENTION

Target Systolic Home Blood Pressure 130-140 mm Hg

Interventions

Strict blood pressure control OTHER

Systolic Blood Pressure Target \< 120 mm Hg (measured at home)

Strict SBP Target

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have
• at least two eGFR in the last three months that are \<=30 mL/min/1.73m2 or
• prior diagnosis of CKD (per electronic chart review) and at least one eGFR \<=30 mL/min/1.73m2
• history of hypertension
• mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide consent to participate in our study.

You may not qualify if:

• Those who:
• are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
• are marginally housed, due to concerns regarding routine follow-up
• are actively participating in a different interventional trial that may affect blood pressure
• are unwilling to consent to participate
• institutionalized individuals or prisoners
• are actively abusing illicit drugs or alcohol
• have a history of poor or doubtful compliance (e.g., frequently missed appointments)
• have office SBP \>170 mmHg
• are already taking \>5 anti-hypertensive medications (any classes, including diuretics) have cognitive impairment prohibiting participation in the study.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 39427725 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

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

Results Point of Contact

• Title: Dr. Elaine Ku
• Organization: University of California, San Francisco Division of Nephrology

elaine.ku@ucsf.edu

415-502-7760

Study Officials

• Raymond Hsu, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Elaine Ku, MD MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: February 10, 2017
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)