CKDNCT04998110
Integrated Palliative Care With Nephrology Care
A study testing Ambulatory Supportive Care in people with CKD, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD
- What is being tested?
- Ambulatory Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2022to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18
- Documented diagnosis of Chronic Kidney Disease stage IV or V
- Speaks Spanish or English fluently
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
Who cannot join
- Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
- 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.
- Pregnant women.
- Not fluent in either English or Spanish
- Any urgent supportive/palliative care needs identified on screening interview.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYC Health + Hospitals / Bellevue
New York, New York, 10016
About this study
Official title: Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care
This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.
Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.
- Conditions
- CKD
- Being tested
- Ambulatory Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Supportive CareOther
Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care Intervention | Experimental | 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. Receives: Other: Ambulatory Supportive Care |
| Usual Care Control | No intervention | The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
This will be reported as the percentage of participants who provide informed consent.
Measured: Month 12
Number of Participants who Maintain Participation in the Study (Retention)
Reported as percentage of participants who signed informed consent, who completed the study.
Measured: Month 12
Average number of clinical visits attended per participant (Retention)
Measured: Month 12
Ability to Collect Planned Data
This will be reported as the percent of completed data surveys
Measured: Month 12
Secondary outcomes (3)
Change in Kidney Disease Quality of Life (KDQOL-36) Score
The KDQOL is a 36-item quality of life survey that includes five domains: Physical Component Summary (PCS), a Mental Component Summary (MCS), Burden of Kidney Disease Score, Symptoms and Problems of Kidney Disease Score, and Effect of Kidney Disease Score. All scores are on a scale of 0-100, with higher scores representing better quality of life.
Measured: Baseline, Month 6
Engagement in Advance Care Planning
Advance care planning will be measured by total number of advance care planning conversations held.
Measured: Baseline, Month 6
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score
The scoring will include 11 questions on the degree of impact kidney-specific symptoms have had on patients over the past week, plus additional items on concerns beyond symptoms, such as information needs, practical issues, and family anxiety. This includes one question that has 15 sub-questions asking about specific physical symptoms. All scores are on a scale of 0-90, with lower scores representing less problems.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start5 Jan 2022
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKDStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Scherer, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998110
- Sponsor's protocol ID
- 21-00507
- Other IDs
- K23DK125840-02
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2021
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Publications
Scherer JS, Wu W, Lyu C, Goldfeld KS, Brody AA, Chodosh J, Charytan D. A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 3;44:101439. doi: 10.1016/j.conctc.2025.101439. eCollection 2025 Apr.
PubMed 40008278
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Integrated Palliative Care With Nephrology Care
- ClinicalTrials.gov ID
- NCT04998110
- Acronym / sponsor ID
- 21-00507
- Conditions
- CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 10 Aug 2021 (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.
This study is a pilot randomized controlled trial testing the effectiveness of integrated ambulatory supportive care visits with standard nephrology outpatient visits for six months in patients with advanced CKD. The study team hypothesizes that patients in the integrated care arm will trend towards improved symptom burden, improved quality of life scores and more engagement in advance care planning.
Primary objectives: To test the impact of integrated ambulatory supportive care in nephrology care on symptom burden. Secondary: To test the impact of integrated ambulatory supportive care on quality of life and engagement in advance care planning and to demonstrate study feasibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Care Intervention | Experimental | Other: Ambulatory Supportive CareThe 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. |
| Usual Care Control | No intervention | –The usual care control arm will be seen at the discretion of their nephrologist, or receive their usual dialysis if on dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Documented diagnosis of Chronic Kidney Disease stage IV or V
- Speaks Spanish or English fluently
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.
Key exclusion criteria (5 listed)
- Exposure to supportive/palliative care in the last six months either inpatient or outpatient.
- 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.
- Pregnant women.
- Not fluent in either English or Spanish
- Any urgent supportive/palliative care needs identified on screening interview.
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 |
|---|---|---|
| Ambulatory Supportive CareAmbulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease | Other | Supportive Care Intervention |
Primary outcome
Recruitment Rate
Time frame: Month 12
This will be reported as the percentage of participants who provide informed consent.
Number of Participants who Maintain Participation in the Study (Retention)
Time frame: Month 12
Reported as percentage of participants who signed informed consent, who completed the study.
Average number of clinical visits attended per participant (Retention)
Time frame: Month 12
Ability to Collect Planned Data
Time frame: Month 12
This will be reported as the percent of completed data surveys
3 secondary outcomes
Change in Kidney Disease Quality of Life (KDQOL-36) Score
Time frame: Baseline, Month 6
Engagement in Advance Care Planning
Time frame: Baseline, Month 6
Change in Integrated Palliative Outcome Score-Renal (IPOS-Renal) Score
Time frame: Baseline, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 40008278Scherer JS, Wu W, Lyu C, Goldfeld KS, Brody AA, Chodosh J, Charytan D. A pilot randomized controlled study of integrated kidney palliative care and chronic kidney disease care implemented in a safety-net hospital: Protocol for a pilot study of feasibility of a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 3;44:101439. doi: 10.1016/j.conctc.2025.101439. eCollection 2025 Apr.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Related trials for CKD
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
Active, not recruitingPhase 4
A Study of Dapagliflozin in Chinese Adult Patients With Chronic Kidney Disease
Chronic Kidney Disease
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
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. This study is not recruiting at the moment.
Jennifer Scherer, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Supportive Care in people with CKD, run by NYU Langone Health at 1 site 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Month 12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04998110, which also lists 1 linked publication.
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 9 Jul 2025.