Supportive Care for Chronic Kidney Disease

Overseen By Haley Gross

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Recent palliative care, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how combining supportive care with regular nephrology visits can benefit individuals with advanced chronic kidney disease (CKD). The researchers aim to determine if this combined care, known as Integrated Palliative Care, can alleviate symptoms, enhance quality of life, and assist with planning for future care needs. Participants will either receive this integrated care or continue with their usual kidney care. Individuals with advanced CKD who have not received supportive care in the past six months may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how integrated care can enhance life quality for CKD patients.

What prior data suggests that integrated palliative care is safe for patients with advanced chronic kidney disease?

Research has shown that integrated palliative care is generally safe for people with chronic kidney disease (CKD). In past studies, patients who received this care experienced better symptom relief than those who only received standard treatments. These studies found no serious safety issues, indicating the treatment was well-tolerated. Most participants did not experience major side effects. Anyone considering joining a trial should discuss potential risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about integrated palliative care for chronic kidney disease because it combines the usual nephrology care with regular supportive care visits. Unlike standard treatments that focus primarily on managing kidney function and symptoms through dialysis or medication, this approach emphasizes holistic care, addressing both physical and emotional needs. This integration aims to improve patients' quality of life by providing consistent and comprehensive support, potentially leading to better overall outcomes for those living with chronic kidney disease.

What evidence suggests that integrated palliative care is effective for chronic kidney disease?

Research has shown that combining palliative care with regular treatment can improve the quality of life for people with advanced chronic kidney disease (CKD). In this trial, participants in the Supportive Care Intervention arm will receive their usual nephrology care integrated with monthly supportive care visits over six months. Patients who receive this care often feel better and visit the emergency room less frequently. One study found that adding palliative care to kidney care led to increased use of hospice services and improved health outcomes. This suggests that incorporating supportive care into standard CKD treatment can help reduce symptoms and enhance overall well-being. The aim is to assist patients in managing their symptoms and planning for future care needs. ^{1 5 6 7 8}

Who Is on the Research Team?

Jennifer Scherer, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced Chronic Kidney Disease (stage IV or V), including those on dialysis, who speak English or Spanish fluently. They must consent to participate and commit to the study's procedures for six months. People who've had palliative care recently, are pregnant, have urgent palliative needs, or can't understand the study due to cognitive issues cannot join.

Inclusion Criteria

I am willing and able to follow the study rules and attend all appointments.

My condition is chronic kidney disease at stage IV or V.

Provision of signed and dated informed consent form

Exclusion Criteria

I have received care to ease symptoms in the last 6 months.

I need urgent care for my symptoms.

Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation, for example not being able to cognitively understand the questions or to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated ambulatory supportive care visits with standard nephrology outpatient visits

6 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Palliative Care

Trial Overview The trial tests if adding supportive care visits to regular kidney disease outpatient appointments helps reduce symptoms and improve quality of life over six months. It also looks at whether this integrated approach increases engagement in planning future medical care.

How Is the Trial Designed?

Group I: Supportive Care Intervention Experimental Treatment 1 Intervention

The supportive care intervention arm will receive their usual ambulatory longitudinal nephrology care integrated with ambulatory supportive care through monthly supportive care visits over six months.

Group II: Usual Care Control Active Control 1 Intervention

The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11851192/

A pilot randomized controlled study of integrated kidney ... This pilot RCT will provide essential data on the feasibility of testing integrated palliative care in CKD care in an underserved setting. These outcomes will ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9717658/

A Pilot Randomized Controlled Trial of Integrated Palliative ... A pilot randomized controlled trial of integrated palliative and nephrology care in patients with CKD stage 5 not on dialysis is feasible.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590059521000649

Nephrology and Palliative Care Collaboration in the ... The study aim was to describe clinicians' perceptions of the clinical and research priorities in CKD care and the main barriers to collaboration.

4. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04294-x

Kidney supportive care in advanced chronic kidney disease: a ... This study systematically reviews and synthesizes healthcare professionals' perspectives on Kidney Supportive Care (KSC) to establish an evidence base for ...

5. ajkd.org ajkd.org/article/S0272-6386(10)01677-X/fulltext

Palliative Care in CKD: The Earlier the Better Patients in this integrated-care group had statistically better quality of life, received more hospice care, and had fewer emergency department visits and ...

6. journals.lww.com journals.lww.com/jasn/fulltext/2025/10001/pilot_randomized_controlled_trial__rct__of.3832.aspx

Pilot Randomized Controlled Trial (RCT) of Integrated Kidney RCTs show integrated palliative care improves symptoms compared with disease directed care, but no similar RCTs exist in CKD. We conducted a pilot RCT of ...

7. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/a-pilot-randomized-controlled-study-of-integrated-kidney-palliati

A pilot randomized controlled study of integrated kidney ... These outcomes include symptom burden, quality of life, and engagement in advance care planning. Discussion: This pilot RCT will provide essential data on the ...

8. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=4970370

A Pilot Randomized Controlled Study of Integrated Kidney ... This pilot study evaluates the feasibility of a randomized clinical trial (RCT) that tests the effectiveness of integrated kidney palliative and ...