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

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.

Study Overview

• Status: Suspended
• Conditions: Hypertension; Chronic Kidney Disease; Bloodpressure
• Intervention / Treatment: Other: Strict blood pressure control

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).

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperkalemia	Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.	Months 1-12 and study end
Achieved Blood Pressure		Months 4-12 and study end
Falls and syncope by self-report or based on emergency room visits	Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit.	Months 1-12 and study end
End-stage Renal Disease	Defined as receipt of chronic dialysis or kidney transplant	Month 1 to study end

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants screened who enroll in trial	Feasibility of enrollment	Months 0-12

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Raymond Hsu, MD MAS, University of California, San Francisco; Principal Investigator: Elaine Ku, MD MAS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2017
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 16-20978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No