Chronic Kidney Disease (Stages 4 and 5)NCT07741357
Kidney RISE: Randomized Integrated Supportive CarE Trial
A study testing Kidney RISE in people with Chronic Kidney Disease (Stages 4 and 5), run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- Kidney RISE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2027to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Receive care at nephrology clinics or dialysis centers associated with each site.
- Have CKD stage IV, V (eGFR < 30 mL/min/1.73m2), or be receiving chronic dialysis
- Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey.
- Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
Who cannot join
- Unable to provide informed consent
- Has received palliative care (inpatient or outpatient) in the last six months.
- Enrolled in hospice
- Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs.
- Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US.
- Pregnant individuals.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Monahan contact
United States2 sites
Emory University
Atlanta, Georgia, 30322
Dio Kavalieratos, MD
NYU Langone Health
New York, New York, 10016
Jennifer Scherer, MD, MS, FASN
About this study
Official title: Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Being tested
- Kidney RISE
- Keywords
- CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney RISEBehavioural
Core components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Kidney Palliative Care | Experimental | Participants will receive integrated kidney palliative care (Kidney RISE) in addition to their usual CKD care. The integrated kidney palliative care consists of 4 kidney palliative care (KPC) intervention visits over 24 weeks by a KPC-trained palliative care provider in person or telehealth, each visit will last between 30-60 minutes. Receives: Behavioral: Kidney RISE |
| Usual Chronic Kidney Disease (CKD) Care | No intervention | Participants in this arm will receive the usual CKD care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Measured: Baseline, Week 12
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Measured: Baseline, Week 24
Secondary outcomes (8)
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.
Measured: Baseline, Week 12
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
The KDQOL-36 is a 36-item short-form survey designed to measure the health-related quality of life for individuals with kidney disease and those on dialysis. Items 1-12 (SF-12): Measures generic physical and mental health functioning. Items 13-16 (Burden of Kidney Disease): Assesses how much kidney disease interferes with daily life. Items 17-28 (Symptoms and Problems): Evaluates common physical issues and symptoms related to kidney failure. Items 29-36 (Effects of Kidney Disease): Focuses on daily impacts like fluid restrictions, work around the house, and personal life. Transformed to a 0-100 scale, where higher scores represent a better quality of life.
Measured: Baseline, Week 24
Number of participants with advance care planning
Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.
Measured: Week 12
Number of participants with advance care planning
Outcome measure will be assessed by chart review. Advance care planning includes proxy, Medical Orders for Life-Sustaining Treatment (MOLST)/Physician/Provider Orders for Life-Sustaining Treatment (POLST), and advance care planning conversations.
Measured: Week 24
Change in Patient Activation Measure-13 (PAM-13) scores
The PAM-13 is a 13-item survey that evaluates a person's knowledge, skills, and confidence in managing their own health and healthcare. 13 statements answered on a 4-point Likert scale (strongly disagree to strongly agree). Scores range from 0-100. Score ≤ 47.0: Disengagement and disbelief; the person may not feel an active role is important. Score 47.1-55.1: Increasing awareness and knowledge, but still lacks confidence to take action. Score 55.2-67.0: Taking action and gaining readiness to manage health behaviors. Score ≥ 67.1: Sustainment; the person adopts and maintains healthy behaviors even under stress.
Measured: Baseline, Week 12
Change in Patient Activation Measure-13 (PAM-13) scores
The PAM-13 is a 13-item survey that evaluates a person's knowledge, skills, and confidence in managing their own health and healthcare. 13 statements answered on a 4-point Likert scale (strongly disagree to strongly agree). Scores range from 0-100. Score ≤ 47.0: Disengagement and disbelief; the person may not feel an active role is important. Score 47.1-55.1: Increasing awareness and knowledge, but still lacks confidence to take action. Score 55.2-67.0: Taking action and gaining readiness to manage health behaviors. Score ≥ 67.1: Sustainment; the person adopts and maintains healthy behaviors even under stress.
Measured: Baseline, Week 24
Change in General Anxiety Disorder-7 (GAD-7) scores
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Measured: Baseline, Week 12
Change in General Anxiety Disorder-7 (GAD-7) scores
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Measured: Baseline, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startMay 2027 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization stratified by receipt of dialysis or not and site location.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Scherer, MD, MS, FASN, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741357
- Sponsor's protocol ID
- 26-00770
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jennifer.scherer@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
- ClinicalTrials.gov ID
- NCT07741357
- Acronym / sponsor ID
- 26-00770
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2027 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of study is to investigate whether adding palliative care to usual chronic kidney disease (CKD) care improves symptoms and quality of life for people with CKD. The primary objectives are to 1) determine efficacy of Kidney Palliative Care (KPC) integrated with CKD care on symptom burden compared with usual CKD care, 2) identify clinical and demographic factors associated with differential responses to KPC, and 3) characterize participant and provider experiences with kidney care and factors influencing implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization stratified by receipt of dialysis or not and site location.
| Arm | Type | Receives |
|---|---|---|
| Integrated Kidney Palliative Care | Experimental | Behavioral: Kidney RISEParticipants will receive integrated kidney palliative care (Kidney RISE) in addition to their usual CKD care. The integrated kidney palliative care consists of 4 kidney palliative care (KPC) intervention visits over 24 weeks by a KPC-trained palliative care provider in person or telehealth, each visit will last between 30-60 minutes. |
| Usual Chronic Kidney Disease (CKD) Care | No intervention | –Participants in this arm will receive the usual CKD care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receive care at nephrology clinics or dialysis centers associated with each site.
- Have CKD stage IV, V (eGFR < 30 mL/min/1.73m2), or be receiving chronic dialysis
- Speak Spanish or English, and report at IPOS-Renal score of ≥ 3 on a screening survey.
- Willing to be randomized to either study arm and to comply with the study procedures for the assigned group.
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Has received palliative care (inpatient or outpatient) in the last six months.
- Enrolled in hospice
- Has any urgent palliative care needs (i.e. severe pain, emotional distress) identified upon screening. Research staff will be trained to recognize these needs.
- Non-English and Non-Spanish speakers to correspond with the populations most impacted by CKD in the US.
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 |
|---|---|---|
| Kidney RISECore components include assessment of symptoms (IPOS-Renal), illness understanding, goals of care, advance care planning, spiritual needs, and screening for health-related social needs (HRSNs) using the validated Centers for Medicare and Medicaid Services (CMS) Accountable Health Communities (AHC) Survey. Plans will address symptom management with evidence-based algorithms, linkage to social or spiritual supports, and shared decision-making appropriate to CKD stage. | Behavioural | Integrated Kidney Palliative Care |
Primary outcome
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
Time frame: Baseline, Week 12
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores
Time frame: Baseline, Week 24
The IPOS-Renal Patient Version includes 10 questions (scored 0-90), with sub-scores for physical symptoms (15 questions, range 0-60), psychological symptoms (four questions, range 0-16), and practical impact of CKD (four questions, range 0-14). Higher scores indicate a higher burden of symptoms and greater distress for the patient.
8 secondary outcomes
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
Time frame: Baseline, Week 12
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
Time frame: Baseline, Week 24
Number of participants with advance care planning
Time frame: Week 12
Number of participants with advance care planning
Time frame: Week 24
Change in Patient Activation Measure-13 (PAM-13) scores
Time frame: Baseline, Week 12
Change in Patient Activation Measure-13 (PAM-13) scores
Time frame: Baseline, Week 24
Change in General Anxiety Disorder-7 (GAD-7) scores
Time frame: Baseline, Week 12
Change in General Anxiety Disorder-7 (GAD-7) scores
Time frame: Baseline, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jennifer.scherer@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Rachel Monahan contact
Jennifer Scherer, MD, MS, FASN principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney RISE in people with Chronic Kidney Disease (Stages 4 and 5), run by NYU Langone Health at 2 sites 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Scherer, MD, MS, FASN (212-263-0705, Jennifer.scherer@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Integrated Palliative Care Outcome Scale - Renal (IPOS-Renal) Patient Version scores (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.