Kidney RISE: Randomized Integrated Supportive CarE Trial
Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
1 other identifier
interventional
280
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2027
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2026
CompletedFirst Posted
Study publicly available on registry
August 3, 2026
CompletedStudy Start
First participant enrolled
May 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
Study Completion
Last participant's last visit for all outcomes
January 1, 2031
August 3, 2026
July 1, 2026
3.3 years
July 29, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Baseline, Week 24
Secondary Outcomes (8)
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
Baseline, Week 12
Change in Kidney Disease Quality of Life 36-Item (KDQOL-36) Short-Form Survey
Baseline, Week 24
Number of participants with advance care planning
Week 12
Number of participants with advance care planning
Week 24
Change in Patient Activation Measure-13 (PAM-13) scores
Baseline, Week 12
- +3 more secondary outcomes
Study Arms (2)
Integrated Kidney Palliative Care
EXPERIMENTALParticipants 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 INTERVENTIONParticipants in this arm will receive the usual CKD care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Emory University
Atlanta, Georgia, 30322, United States
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Scherer, MD, MS, FASN
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2026
First Posted
August 3, 2026
Study Start (Estimated)
May 1, 2027
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
January 1, 2031
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jennifer.scherer@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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.