ClinicalTrials.gg
RecruitingNCT07633145CKD-LIFEUpdated Sep 22, 2026

Lifestyle Intervention In CKD

An interventional study of Multi-component lifestyle intervention and Usual Care Control in Chronic Kidney Disease and Hypertension, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Duke University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Renal Insufficiency, Chronic by Duke University — 4 open to participants now, 4 under way, none of them phase 3. Renal Insufficiency, Chronic · Duke University.

Planned enrollment
9th of 18
152 · median 136
Started
2026
the only one that year
No phase
15 of 20
4 open now
Registered
20th of 20
by date

Among the 20 studies in Renal Insufficiency, Chronic by Duke University, this one is the 9th largest by planned enrollment of the 18 interventional ones, is the only one that started in 2026, is one of 15 with no phase, and was the 20th registered.

By phase

20 studies; the count open now beside each. This study's row is marked.

No phasethis study15 · 4 open
Observational2 · 0 open
Phase 11 · 0 open
Phase 21 · 0 open
Phase 41 · 0 open

By the year they started

First in 2008; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 136 across the 18 interventional studies, 3,953 across the 2 observational. Of the 16 that completed or were terminated, 6 (38%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 20 studies in Renal Insufficiency, Chronic by Duke University, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Chronic Kidney Disease
  • Hypertension

Keywords

  • chronic kidney disease
  • blood pressure
  • lifestyle intervention
  • diet
  • exercise
  • weight management
  • cardiac rehabilitation
  • hypertension
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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);
  • of 15-44 ml/min/1.73m2 at screening visit
  • agreeable to randomization to either of the 2 study arms

Exclusion criteria

Exclusion Criteria:

  • 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 ( \<18.5 kg/m2)
  • planned weight loss surgery in 1 year
  • 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 ( 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    Lifestyle Intervention

    Participants receive CKD education plus a 12-week cardiac rehabilitation-based lifestyle program including supervised exercise, DASH-based diet counseling, and weight management.

    Behavioral: Multi-component lifestyle intervention

  • Active comparator
    Usual Care

    Participants receive CKD education only.

    Behavioral: Usual Care Control

Interventions

  • BehavioralMulti-component lifestyle intervention

    Cardiac rehabilitation-based program including supervised exercise, DASH-based dietary counseling, and wellness support over 12 weeks.

  • BehavioralUsual Care Control

    Routine medical care in addition to 1) one 30-minute counseling session with dietician and 2) an exercise prescription

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 months, 9 months

Secondary outcomes

  1. Change in DASH diet adherence score

    Completion of 24-hour dietary recalls using the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool

    Time frame: Baseline, 3 months, 9 months

  2. 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

    Time frame: Baseline, 3 months, 9 months

  3. 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.

    Time frame: Baseline, 3 months, 9 months

  4. 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).

    Time frame: Baseline, 3 months, 9 months

  5. 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.

    Time frame: Baseline, 3 months, 9 months

  6. 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.

    Time frame: Baseline, 3 months, 9 months

  7. 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.

    Time frame: Baseline, 3 months, 9 months

07

Study locations

1 of 1 sites recruiting
  • Sarah W Stedman Nutrition & Metabolism Center
    Durham, North Carolina 27705, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2026 (actual). Primary completion is estimated for Jun 2029, 35 months after the start.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 35 months is above that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 8, 2026
StartActual
Jul 30, 2026
Primary completionEst.
Jun 30, 2029
CompletionEst.
Jun 30, 2030
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07633145
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Jun 8, 2026
Start date
Jul 30, 2026
Primary completion
Jun 30, 2029 (estimated)
Completion
Jun 30, 2030 (estimated)
Last update
Sep 22, 2026

Study contacts

Crystal Tyson, MD
Contact
crystal.simpson@duke.edu
919-660-6860
Crystal Tyson, MD, MHS
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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