Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-01 @ 6:21 AM
Study NCT ID:
NCT02975505
Status:
TERMINATED
Last Update Posted:
2025-02-17
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to challenges in recruitment and visits during COVID
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERFORMANCE
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.
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 usual care (130-140 mmHg).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: