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Self-Managed Blood Pressure Control for Chronic Kidney Disease
Phase 3
Recruiting
Led By Diana Jalal, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age >= 18 years
CKD stage 3 or 4 (estimated GFR: 15-59 mL/min/1.73m2) or Stage 2 CKD (estimated GFR 60-89 mL/min/1.73m2) with urinary albumin/creatinine ratio (ACR 300 mg/g if no DM and 30 mg/g if with DM)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial will test if patients can better manage their blood pressure with the help of a clinical pharmacist and if this lowers their blood pressure more than the standard care.
Who is the study for?
This trial is for Veterans aged 18 or older with moderate chronic kidney disease (CKD) and uncontrolled high blood pressure. They must not be pregnant, have severe hypertension, liver disease, heart failure, cognitive decline due to dementia, or a life expectancy less than one year.Check my eligibility
What is being tested?
The study compares two methods: patients managing their own blood pressure medication under a pharmacist's guidance versus standard care with home monitoring of blood pressure. It aims to see which method better lowers blood pressure in CKD patients.See study design
What are the potential side effects?
Potential side effects may include issues related to incorrect self-management like abnormal blood pressure levels. However, since the intervention involves non-drug measures (self-monitoring and management), significant side effects are unlikely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My kidney function is reduced, and I may have protein in my urine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in standardized office BP
Secondary outcome measures
Change in conventional office BP
Change in standardized office diastolic BP
Home BP readings
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Self-managementExperimental Treatment1 Intervention
Patients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.
Group II: Self-monitoringActive Control1 Intervention
Patients monitor their home BP and contact their provider if the BP is above the goal.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,024 Total Patients Enrolled
Diana Jalal, MDPrincipal InvestigatorIowa City VA Health Care System, Iowa City, IA
1 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is consistently higher than 140/90.You are expected to live less than 1 year.Your blood pressure drops significantly when you stand up after sitting or lying down for a few minutes.I am 18 years old or older.I have high blood pressure not controlled by 4 different medications.I have severe heart failure.I have severe memory loss due to dementia.Your blood pressure is very high, with a systolic reading above 180.My kidney function is reduced, and I may have protein in my urine.My kidney function is severely reduced.I have severe liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Self-management
- Group 2: Self-monitoring
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can people sign up for this experiment right now?
"This specific study, as indicated by clinicaltrials.gov is no longer recruiting patients for participation. Although this particular trial is not looking for any more volunteers, there are 513 other trials that are still actively recruiting individuals."
Answered by AI
Has the FDA released a statement on self-management of blood pressure medications?
"Self-management of BP medications received a score of 3 from our team at Power. This is due to the fact that it is a Phase 3 trial, meaning that efficacy has been supported by some data and safety has been backed up by multiple rounds of research."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am stage 3 kidney disease and i'd like to know more about what this trial is about and find out if there's a possibility of video increasing the health of my kidneys.
PatientReceived 1 prior treatment
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