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Eligibility
for people ages 16 years and up
Location
at San Francisco, California
Dates
study started
Principal Investigator

Description

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.

Details

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 60 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).

Keywords

Chronic Kidney Disease Bloodpressure Hypertension

Eligibility

You can join if…

Open to people ages 16 years and up

We will include 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 three months apart 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.

You CAN'T join if...

We will exclude 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
  • have a functioning kidney transplant and are on immunosuppression, due to potential differences in risk for outcomes of interest in this population)
  • 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.

Location

Details

Status
not yet accepting patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT02975505
Phase
Phase 2
Lead Scientist
Raymond Hsu
Study Type
Interventional
Last Updated
November 2016
I'm interested in this study!