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

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ClinicalTrials.gov Identifier: NCT02975505
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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 blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Bloodpressure Hypertension Other: Strict blood pressure control Not Applicable

Detailed Description:
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 130-140 mm Hg (usual care group).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Strict SBP Target
Target Systolic Blood Pressure <120 mm Hg
Other: Strict blood pressure control
Systolic Blood Pressure Target < 120 mm Hg (measured at home)

No Intervention: Usual SBP Target
Target Systolic Blood Pressure 130-140 mm Hg



Primary Outcome Measures :
  1. Hyperkalemia [ Time Frame: Months 1-12 and study end ]
    Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.

  2. Achieved Blood Pressure [ Time Frame: Months 4-12 and study end ]
  3. Falls and syncope by self-report or based on emergency room visits [ Time Frame: Months 1-12 and study end ]
    Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit.

  4. End-stage Renal Disease [ Time Frame: Month 1 to study end ]
    Defined as receipt of chronic dialysis or kidney transplant


Secondary Outcome Measures :
  1. Number of participants screened who enroll in trial [ Time Frame: Months 0-12 ]
    Feasibility of enrollment



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have

  1. at least two eGFR in the last three months that are <=30 mL/min/1.73m2 or
  2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR <=30 mL/min/1.73m2
  3. history of hypertension
  4. mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide consent to participate in our study.

Exclusion criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975505


Contacts
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Contact: Elaine Ku, MD MAS 415-353-2507 Elaine.Ku@ucsf.edu
Contact: Divya Seth, BA 916-476-2041 divya.seth@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Divya Seth, BA    916-476-2041    divya.seth@ucsf.edu   
Contact: Elaine Ku, MD MAS       elaine.ku@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Raymond Hsu, MD MAS University of California, San Francisco
Principal Investigator: Elaine Ku, MD MAS University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02975505    
Other Study ID Numbers: 16-20978
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency