Chronic Kidney DiseasesSTEPS-LTNCT07515794
System Interventions to Achieve Early and Equitable Transplants Study - Long-Term
An observational study of Chronic Kidney Diseases, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
STEPS-LT is an extension of the System Interventions to Achieve Early and Equitable Transplants (STEPS) study. STEPS-LT will follow participants that previously completed the STEPS study to evaluate sustained behavioral activation and transplant-related milestones among participants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 793 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2026to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants previously enrolled in STEPS study will participate in this extension study (STEPS-LT).
Who may be able to join
- STEPS study participants who did not withdraw consent during the study or have not died.
Who cannot join
- Not previously enrolled in STEPS study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
About this study
Official title: System Interventions to Achieve Early and Equitable Transplants (STEPS) Study (and Long-Term STEPS-LT)
STEPS-LT is an extension of the System Interventions to Achieve Early and Equitable Transplants (STEPS) study. STEPS-LT will follow participants that previously completed the STEPS study to evaluate sustained behavioral activation and transplant-related milestones among participants.
Read the detailed description
STEPS-LT extends the original STEPS study for long-term follow-up. Participants will be followed for an additional 36 months to evaluate sustained behavioral activation and transplant-related milestones among participants originally enrolled in STEPS. STEPS-LT maintains the original STEPS study cohort and will collect additional outcomes data through questionnaires, electronic health records, and the Scientific Registry of Transplant Recipients. This extended follow-up will assess participants' engagement in transplant readiness behaviors and transplant barriers they encounter over time.
- Conditions
- Chronic Kidney Diseases
- 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.
| Study group | Role | What they receive |
|---|---|---|
| STEPS Health Systems Surveillance and Outreach Intervention | Not described | |
| Usual Kidney care | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Physician Discussions
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Patient Reported Family Discussions
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Measured: month 6, months 12, months 18, month 24, month 30, month 36
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: month 6, months 12, months 18, month 24, month 30, month 36
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: month 6, months 12, months 18, month 24, month 30, month 36
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: month 6, months 12, months 18, month 24, month 30, month 36
Secondary outcomes (7)
Health System Reported Live Donor Inquires to Transplant Center
the number of participants that made an inquiry to the transplant center related to donors as reported in health system electronic health record or questionnaires
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Receipt of Live Donor Kidney Transplant
The number of participants that completed their live kidney donor transplant as reported by the electronic health record or questionnaire
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Receipt of Deceased Donor Kidney Transplant
The number of participants that completed their deceased kidney donor transplant as reported by the electronic health record or questionnaire
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Placement on Deceased Kidney Donor Waitlist
The number of participants that have been placed on the deceased kidney donor waitlist as reported in the electronic health record or United Network of Organ Sharing
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Completion of Transplant Evaluation
Number of participants that said "yes" to completion of transplant evaluation as reported in health system electronic health record and administrative reports
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Initiation of Transplant Evaluation
Number of patients that said "yes" to the initiation of transplant evaluation as reported in health system electronic health record and administrative reports
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Patient Reported Kidney Transplant Knowledge
Number of questions patients correctly answer measured by patient report in questionnaire
Measured: month 6, months 12, months 18, month 24, month 30, month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start11 Jun 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 793 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Geisinger Clinic, University of Mississippi Medical Center, Duke Health
- Responsible party
- Sponsor
- Investigators
- Ebony Boulware, M.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515794
- Sponsor's protocol ID
- IRB00097407.1
- Other IDs
- LTF-2024C2-39695
- Acronym
- STEPS-LT
- Status last verified
- Feb 2026
- First submitted
- 31 Mar 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 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 (and Long-Term STEPS-LT)
- ClinicalTrials.gov ID
- NCT07515794
- Acronym / sponsor ID
- STEPS-LT / IRB00097407.1
- Conditions
- Chronic Kidney Diseases
- Keywords
- Kidney transplant, Living donor kidney transplant
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 793 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Geisinger Clinic, University of Mississippi Medical Center, Duke Health
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 7 Apr 2026 (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.
STEPS-LT is an extension of the System Interventions to Achieve Early and Equitable Transplants (STEPS) study. STEPS-LT will follow participants that previously completed the STEPS study to evaluate sustained behavioral activation and transplant-related milestones among participants.
Detailed description
STEPS-LT extends the original STEPS study for long-term follow-up. Participants will be followed for an additional 36 months to evaluate sustained behavioral activation and transplant-related milestones among participants originally enrolled in STEPS. STEPS-LT maintains the original STEPS study cohort and will collect additional outcomes data through questionnaires, electronic health records, and the Scientific Registry of Transplant Recipients. This extended follow-up will assess participants' engagement in transplant readiness behaviors and transplant barriers they encounter over time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPS Health Systems Surveillance and Outreach Intervention | – | – |
| Usual Kidney care | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants previously enrolled in STEPS study will participate in this extension study (STEPS-LT).
Key inclusion criteria (1 listed)
- STEPS study participants who did not withdraw consent during the study or have not died.
Key exclusion criteria (1 listed)
- Not previously enrolled in STEPS study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Reported Physician Discussions
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
number of times patient talked to physician regarding kidney transplant measured by patient report in questionnaire
Patient Reported Family Discussions
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
number of times patient talked to family regarding kidney transplant measured by patient reported in questionnaire
Patient Reported Initiation of Transplant Evaluation
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
number of patients that said "yes" to the initiation of transplant evaluation measured by patient report in questionnaire
Patient Reported Identification of a Living Donor
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Number of patients that said "yes" to the identification of a living donor measured by patient report in questionnaire
Patient Reported Completion of Transplant Evaluation
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Number of patients that said "yes" to the completion of transplant evaluation measured by patient report in questionnaire
7 secondary outcomes
Health System Reported Live Donor Inquires to Transplant Center
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Receipt of Live Donor Kidney Transplant
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Receipt of Deceased Donor Kidney Transplant
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Placement on Deceased Kidney Donor Waitlist
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Completion of Transplant Evaluation
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Health System Reported Initiation of Transplant Evaluation
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Patient Reported Kidney Transplant Knowledge
Time frame: month 6, months 12, months 18, month 24, month 30, month 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.
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?
An observational study of 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient Reported Physician Discussions (time frame: month 6, months 12, months 18, month 24, month 30, month 36). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.