Chronic Kidney DiseasesNCT05014256
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
A study testing STEPS Health System Outreach intervention in people with Chronic Kidney Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- STEPS Health System Outreach intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,168 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2022to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide oral informed consent
- Male or female, aged 18 to <=75 years
- Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
- English speaking with adequate ability to hear and understand questions over the phone
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Male or female, aged <18 or > 75 years
- Non-English speaking
- Lack of ability to hear and comprehend verbal communication.
- Patients on dialysis
- Deceased
- Hospice/palliative care
Show all 9Show fewer
- Prior kidney transplant
- Currently waitlisted at any transplant center
- Self-reported terminal illness or receipt of hospice services
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
About this study
This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.
- Conditions
- Chronic Kidney Diseases
- Being tested
- STEPS Health System Outreach intervention
- Keywords
- Kidney transplant, Living donor kidney transplant
- 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.
STEPS Health System Outreach interventionBehavioural
STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach
| Study group | Role | What they receive |
|---|---|---|
| STEPS Health System Surveillance and Outreach intervention | Experimental | Not described Receives: Behavioral: STEPS Health System Outreach intervention |
| Usual Kidney Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health system reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports
Measured: 18 months
Secondary outcomes (12)
Live donor inquires to transplant center
the number of participants that made an inquiry to the transplant center related to live donors as reported in EHR or from questionnaire
Measured: 6 months, 12 months, 18 months
Live kidney donor transplants
The number of participants that completed their live kidney donor transplant as reported by the EHR or questionnaire
Measured: 6 months, 12 months, 18 months
Placement on deceased kidney donor waitlist
The number of patients that have been placed on the deceased kidney donor waitlist as reported in the EHR or UNOS
Measured: 6 months, 12 months, 18 months
Deceased kidney donor transplants
The number of patients that received a deceased kidney donor transplant as reported in EHR or USRDS
Measured: 6 months, 12 months, 18 months
Health system reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system EHR and Administrative reports
Measured: 18 months
Patient reported physician discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported family discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported initiation of transplant evaluation
Number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported completion of transplant evaluation
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported identification of a living donor
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported kidney transplant knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
Measured: baseline, 6 months, 12 months, 18 months
Patient reported empowerment
Calculation of scaled questions from the adapted DES-SF form using a range of 1-5 for each question, with 5 being the best outcome, measured by patient report in questionnaire.
Measured: baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start2 Apr 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 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 Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health, Geisinger Clinic, University of Mississippi Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Ebony Boulware, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014256
- Sponsor's protocol ID
- IRB00097407
- Other IDs
- 7U01DK127918-02, IHS-2020C1-19350-IC
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boulware LE, Ephraim PL, Shafi T, Green JA, Browne T, Strigo TS, Peskoe S, Wilson J, Lokhnygina Y, Alkon A, Jackson GL, Ellis MJ, Sudan D, Cameron B, Vaitla PK, Cabacungan A, Brubaker L, Obermiller EL, Diamantidis CJ. System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial. Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6.
PubMed 40199386
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System Interventions to Achieve Early and Equitable Transplants (STEPS) Study
- ClinicalTrials.gov ID
- NCT05014256
- Acronym / sponsor ID
- IRB00097407
- Conditions
- Chronic Kidney Diseases
- Keywords
- Kidney transplant, Living donor kidney transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,168 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Northwell Health, Geisinger Clinic, University of Mississippi Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Patient-Centered Outcomes Research Institute
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 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 project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS Health System Surveillance and Outreach intervention | Experimental | Behavioral: STEPS Health System Outreach intervention |
| Usual Kidney Care | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide oral informed consent
- Male or female, aged 18 to <=75 years
- Presence of CKD (2 eGFRs <60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
- English speaking with adequate ability to hear and understand questions over the phone
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (9 listed)
- Male or female, aged <18 or > 75 years
- Non-English speaking
- Lack of ability to hear and comprehend verbal communication.
- Patients on dialysis
- Deceased
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 |
|---|---|---|
| STEPS Health System Outreach interventionSTEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach | Behavioural | STEPS Health System Surveillance and Outreach intervention |
Primary outcome
Health system reported completion of transplant evaluation
Time frame: 18 months
Number of patients that said "yes" to the completion of transplant evaluation as reported in health system EHR and Administrative reports
12 secondary outcomes
Live donor inquires to transplant center
Time frame: 6 months, 12 months, 18 months
Live kidney donor transplants
Time frame: 6 months, 12 months, 18 months
Placement on deceased kidney donor waitlist
Time frame: 6 months, 12 months, 18 months
Deceased kidney donor transplants
Time frame: 6 months, 12 months, 18 months
Health system reported initiation of transplant evaluation
Time frame: 18 months
Patient reported physician discussions
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported family discussions
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported initiation of transplant evaluation
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported completion of transplant evaluation
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported identification of a living donor
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported kidney transplant knowledge
Time frame: baseline, 6 months, 12 months, 18 months
Patient reported empowerment
Time frame: baseline, 6 months, 12 months, 18 months
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 2 Oct 2026.
- Derived from this study: PubMed 40199386Boulware LE, Ephraim PL, Shafi T, Green JA, Browne T, Strigo TS, Peskoe S, Wilson J, Lokhnygina Y, Alkon A, Jackson GL, Ellis MJ, Sudan D, Cameron B, Vaitla PK, Cabacungan A, Brubaker L, Obermiller EL, Diamantidis CJ. System Interventions to Achieve Early and Equitable Kidney Transplants (STEPS): Protocol for STEPS, a randomized comparative effectiveness clinical trial. Contemp Clin Trials. 2025 Jun;153:107911. doi: 10.1016/j.cct.2025.107911. Epub 2025 Apr 6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ebony Boulware, M.D. principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPS Health System Outreach intervention in people with Chronic Kidney Diseases, run by Wake Forest University Health Sciences 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 9 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 2 Oct 2026. 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?
Health system reported completion of transplant evaluation (time frame: 18 months). 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 NCT05014256, 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 2 Oct 2026.