Chronic Kidney DiseasePERFORMANCENCT02975505

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

A study of Chronic Kidney Disease and Bloodpressure, run by University of California, San Francisco at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 16 years and older
Conditions the study is for: Chronic Kidney Disease, Bloodpressure, Hypertension
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteUnited States
Study dates: 10 Feb 2017to 18 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

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.

Read the 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).

Conditions: Chronic Kidney Disease, Bloodpressure, Hypertension
Being tested: Strict blood pressure control
Medical subject headings: Renal Insufficiency, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Strict blood pressure controlOther
Systolic Blood Pressure Target < 120 mm Hg (measured at home)

Study groups in NCT02975505
Study group	Role	What they receive
Strict SBP Target	Experimental	Target Systolic Home Blood Pressure <120 mm Hg Receives: Other: Strict blood pressure control
Usual SBP Target	No intervention	Target Systolic Home Blood Pressure 130-140 mm Hg

What is being measured

The primary outcome is the main question the study is designed to answer.

Achieved Clinic Systolic Blood Pressure
Achieved clinic SBP at month 12
Measured: At month 12
Difference in Clinic SBP Between the Two Arms
Incorporating achieved mean SBP data between months 4-12
Measured: 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
Measured: Months 0-12

Secondary outcomes (1)

Screening to Enrollment Ratio
This is the number of potential participants screened as eligible to the number who agree to enroll
Measured: From baseline entry through the end of Year 3 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 201718 Jul 2021

First posted29 Nov 2016 (estimated)
Study start10 Feb 2017
Primary completion18 Jul 2021
Study completion18 Jul 2021

Why it stopped: Due to challenges in recruitment and visits during COVID

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02975505
Sponsor's protocol ID: 16-20978
Acronym: PERFORMANCE
Status last verified: Feb 2025
First submitted: 22 Nov 2016
Last updated: 17 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39427725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
ClinicalTrials.gov ID: NCT02975505
Acronym / sponsor ID: PERFORMANCE / 16-20978
Conditions: Chronic Kidney Disease, Bloodpressure, Hypertension
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to challenges in recruitment and visits during COVID
Enrolment: 108 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Study start: 10 Feb 2017 (actual)
Primary completion: 18 Jul 2021 (actual)
Study completion: 18 Jul 2021 (actual)
First posted: 29 Nov 2016 (estimated)
Results: Posted 17 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Strict SBP Target	Experimental	Other: Strict blood pressure controlTarget Systolic Home Blood Pressure <120 mm Hg
Usual SBP Target	No intervention	–Target Systolic Home Blood Pressure 130-140 mm Hg

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Strict blood pressure controlSystolic Blood Pressure Target < 120 mm Hg (measured at home)	Other	Strict SBP Target

Primary outcome

Achieved Clinic Systolic Blood Pressure
Time frame: At month 12
Achieved clinic SBP at month 12
Difference in Clinic SBP Between the Two Arms
Time frame: Months 4-12
Incorporating achieved mean SBP data between months 4-12
Hyperkalemia, Syncope, Falls, ESKD
Time frame: Months 0-12
Potassium >=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization

1 secondary outcome

Screening to Enrollment Ratio
Time frame: From baseline entry through the end of Year 3 of study

Results and safety

Results posted to the registry on 17 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual SBP Target	42	34
Strict SBP Target	66	59

Primary outcome: Achieved Clinic Systolic Blood Pressure

Time frame: At month 12. Mean (Standard Deviation). Unit: mmHg

Measure	Usual SBP Target n = 42	Strict SBP Target n = 66
Value	138.2 (5.3)	124.7 (3.8)

Primary outcome: Difference in Clinic SBP Between the Two Arms

Time frame: Months 4-12. Mean (95% Confidence Interval). Unit: mmHg

Measure	Overall Trial n = 108
Value	11.7 (7.5 to 16)

Overall Trial: beta: 11.7 (95% CI 7.5 to 16), p <0.05, Mixed Models Analysis

Population analysed: Difference is measured between months 4-12

Primary outcome: Hyperkalemia, Syncope, Falls, ESKD

Time frame: Months 0-12. Count of participants. Unit: Participants

Measure	Strict SBP Control n = 66	Usual SBP Control n = 42
Hyperkalemia	2	2
Syncope	1	3
Falls	9	7
Dialysis or (re)-transplant	3	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Between baseline and year 4 of study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Strict SBP Target	30 of 66 (45.5%)	18 of 66 (27.3%)	5 of 66
Usual SBP Target	22 of 42 (52.4%)	10 of 42 (23.8%)	2 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39427725Ku 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.
Individual participant dataSharing planned: No

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End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond Hsu, MD MAS principal investigator

University of California, San Francisco

Elaine Ku, MD MAS principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Chronic Kidney Disease and Bloodpressure, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achieved Clinic Systolic Blood Pressure (time frame: At month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.