Chronic Kidney DiseaseCKD-LIFENCT07633145
Lifestyle Intervention In CKD
A study testing Multi-component lifestyle intervention in people with Chronic Kidney Disease and Hypertension, run by Duke University at 1 site in United States.
Trial summary
This research study will test whether a 12-week healthy lifestyle program offered through a cardiac rehabilitation center can help lower blood pressure and improve kidney health in adults with advanced chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- Multi-component lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to 30 Jun 2030
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black race; ≥18 years old
- history of hypertension
- SBP ≥120 or DBP ≥80 mm Hg average of three measurements at screening visit (per KDIGO recommended SBP target of <120 mm Hg)48
- Stable anti-hypertensive medication regimen (i.e., no medication changes 4 weeks prior to enrollment);
- eGFR of 15-44 ml/min/1.73m2 at screening visit
- agreeable to randomization to either of the 2 study arms
Who cannot join
- currently receiving or needing dialysis; having received or needing a kidney transplant
- acute kidney injury at time of screening
- average SBP ≥ 180 mm Hg or DBP ≥ 110 mm Hg at screening
- Exaggerated systolic response during ETT (e.g., SBP >210 mmHg in men or >190 mmHg in women)
- underweight (BMI <18.5 kg/m2)
- planned weight loss surgery in 1 year
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- a score of 27 or higher on the BP medication adherence scale
- cardiac condition that would preclude participation in aerobic exercise training, including severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on screening treadmill testing), severe heart failure (NYHA Class 3 or 4), high grade arrhythmias, severe valvular heart disease
- severe asthma or chronic obstructive lung disease
- musculoskeletal or neurologic conditions that would preclude participation in aerobic exercise training
- a major psychiatric disorder
- illicit drug abuse
- current alcohol consumption >14 drinks/week for men and >7 drinks/week for women
- pregnant or planned pregnancy within 1 year
- gastric bypass surgery within the last 2 years
- a life-limiting comorbid medical condition, such as cancer.
- physical limitation, gait instability, or need for continuous weight-bearing support that, in the opinion of study staff, would prevent safe completion of exercise treadmill testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sarah W Stedman Nutrition & Metabolism Center
Durham, North Carolina, 27705
Susanne Danus, 919-681-4453, susanne.danus@duke.edu
Heather Taylor, 919-684-5671, heather.l.taylor@duke.edu
About this study
Official title: Multi-component Lifestyle Intervention to Improve Outcomes in Chronic Kidney Disease
This research study will test whether a 12-week healthy lifestyle program offered through a cardiac rehabilitation center can help lower blood pressure and improve kidney health in adults with advanced chronic kidney disease. Participants will be randomly assigned to either routine kidney health education or take part in a program that includes healthy eating guidance, supervised exercise sessions, and wellness coaching. The goal of the study is to determine whether this program can improve blood pressure and other factors linked to worsening kidney disease.
Read the detailed description
This single-site randomized controlled trial will evaluate the blood pressure and kidney effects of a 12-week structured, cardiac rehabilitation-based lifestyle intervention in adults with advanced chronic kidney disease. Participants will be randomized to usual care or a multi-component, cardiac rehabilitation center-based lifestyle intervention, including diet modification, supervised exercise, and wellness counseling. The study aims to determine whether the intervention improves systolic blood pressure and related determinants of chronic kidney disease progression.
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- Multi-component lifestyle intervention, Usual Care Control
- Keywords
- chronic kidney disease, blood pressure, lifestyle intervention, diet, exercise, weight management, cardiac rehabilitation, hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component lifestyle interventionBehavioural
Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.
Usual Care ControlBehavioural
Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management. Receives: Behavioral: Multi-component lifestyle intervention |
| Usual Care | Active comparator | Participants receive CKD education only. Receives: Behavioral: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinic systolic blood pressure (SBP)
Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (7)
Change in DASH diet adherence score
Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool
Measured: Baseline, 3 months, 9 months
Change in 24-hour urinary sodium-to-potassium ratio
one 24-hour urine sample will be collected to objectively assess diet adherence to the DASH diet using biomarkers, such as sodium and potassium
Measured: Baseline, 3 months, 9 months
Change in 6-minute walk test
Participants will be instructed to walk as far as possible for six minutes along a flat, straight course, with standardized encouragement provided at set intervals in accordance with American Thoracic Society guidelines. The total distance walked (in meters) is recorded.
Measured: Baseline, 3 months, 9 months
Change in 24-hour urine albumin excretion
Urine albumin and creatinine concentrations will be determined from one 24-hour urine collection to assess for albuminuria (or from random sample in the event 24-hour sample cannot be collected).
Measured: Baseline, 3 months, 9 months
Change in clinic diastolic blood pressure (DBP)
Three BP values obtained one minute apart will be obtained and averaged to define clinic BP for that time point.
Measured: Baseline, 3 months, 9 months
Change in 24-hour systolic blood pressure (SBP)
Blood pressure monitor will be provided to participants to take home. Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period.
Measured: Baseline, 3 months, 9 months
Change in 24-hour diastolic blood pressure (DBP)
Blood pressure monitor will be provided to participants to take home. Monitor will be programmed to take BP measurements every 20-30 minutes during waking hours and every 30-60 minutes during the nighttime sleep period.
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start30 Jul 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Crystal Tyson, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633145
- Sponsor's protocol ID
- PRO00118256
- Other IDs
- 1R61HL178691
- Acronym
- CKD-LIFE
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No