Kidney RISE: Randomized Integrated Supportive CarE Trial | NCT07741357

NCT07741357

Overview

NCT ID: NCT07741357
Lead Sponsor: NYU Langone HealthOTHER
Official Title: Phase II Multi-Site Randomized Controlled Trial Testing Integrated Kidney Palliative Care Compared With Usual Chronic Kidney Disease Care (Kidney RISE)
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.
Conditions: Chronic Kidney Disease (Stages 4 and 5)

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: May 2027Estimated
Primary Completion Date: Aug 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 280Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Jennifer Scherer, MD, MS, FASNContact
Jennifer.scherer@nyulangone.org

Similar Studies

Participant Group/Arms

Integrated Kidney Palliative CareExperimental

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.

Behavioral: Kidney RISE

Usual Chronic Kidney Disease (CKD) CareNo Intervention

Participants in this arm will receive the usual CKD care.