Kidney TransplantAATAPNCT06707038
Improving Access to Renal Transplantation for Underserved Black Communities
A study testing AATAP intervention in people with Kidney Transplant and ESRD (End Stage Renal Disease), run by Northwestern University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are: Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant?… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplant, ESRD (End Stage Renal Disease)
- What is being tested?
- AATAP intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 6 May 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
- self-identify as Black or African American;
- 18 to 75 years of age
- have an eGFR < 20 or End Stage Renal Disease Diagnosis;
- screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns);
- medically eligible to begin transplant evaluation process determined by transplant team
Who cannot join
- other racial groups
- participants who have previously received a transplant;
- pregnant women;
- participants who screen negative on the screener;
- children less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are:
Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team?
Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.
- Conditions
- Kidney Transplant, ESRD (End Stage Renal Disease)
- Being tested
- AATAP intervention
- Keywords
- Heath Services Research, Intervention
- 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.
AATAP interventionBehavioural
AATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist
| Study group | Role | What they receive |
|---|---|---|
| AATAP (intervention) Arm | Experimental | One clinic visit with all transplant providers, racially concordant care team, dedicated social worked. This will incorporate: Cultural congruency, trust, health literacy and psychological support. Questionnaires also to be administered Receives: Behavioral: AATAP intervention |
| Standard of Care (Control) Arm | No intervention | Separate visits with nephologist, surgeons and social worker. This arm will follow common standard of care at the site. Questionnaires also to be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Listing status for each Arm by month 12
Listing (active or inactive) status by month 12
Measured: 12 months from time of enrollment
Secondary outcomes (3)
Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale
Scoring/T-Score Metric: The T-score metric is standardized with a mean of 50 and a standard deviation (SD) of 10. This means a T-score of 50 represents the average score of the reference population, and each 10-point deviation represents one standard deviation above or below the mean.
Minimum and Maximum Values: The T-score typically ranges from 20 to 80, though this can vary slightly depending on the specific population and scoring method used.
Interpretation: Higher T-scores indicate better health outcomes, while lower T-scores indicate worse health outcomes.
Measured: at enrollment and at 12 months after enrollment
Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
Scoring: The PKDSMS uses an average score on a five-point Likert scale, where respondents rate their self-management abilities.
Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low self-efficacy and 5 indicating high self-efficacy.
Interpretation: Higher scores indicate better self-management and higher confidence in managing kidney dialysis.
Measured: at enrollment and at 12 months after enrollment
trust in care received by transplant team using Adapted Trust in Physicians Scale
Scoring: This scale typically uses a five-point Likert format, where respondents rate their level of agreement with various statements about their trust in their physicians. The response options range from "strongly disagree" to "strongly agree".
Minimum and Maximum Values: The scale ranges from 1 to 5, with 1 indicating low trust and 5 indicating high trust.
Interpretation: Higher scores indicate greater trust in the transplant team, while lower scores indicate less trust.
Measured: at enrollment and at 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Apr 2025
- Primary completion6 May 2025
- Study completion6 May 2025
Why it stopped: Federal funding was no longer viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigators will use a 1:1 allocation ratio of randomization to intervention and control. Randomization will be stratified by sex (male, female) and age (divided into 2 categories). Participants will be assigned to a randomization group upon completing the eligibility screener and consent has been obtained, which will occur after the patient has attended the Roundtable visit and completed baseline questionnaires, but before their first visit with the center.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tampa General Hospital
- Responsible party
- Principal investigator, Daniela Ladner, Northwestern University
- Investigators
- Daniela Ladner, MD, MPH, FACS, FAST, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707038
- Sponsor's protocol ID
- STU00223027
- Other IDs
- U01DK137258-01
- Acronym
- AATAP
- Status last verified
- May 2025
- First submitted
- 21 Nov 2024
- Last updated
- 9 May 2025
- 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 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Renal Transplantation for Underserved Black Communities
- ClinicalTrials.gov ID
- NCT06707038
- Acronym / sponsor ID
- AATAP / STU00223027
- Conditions
- Kidney Transplant, ESRD (End Stage Renal Disease)
- Keywords
- Heath Services Research, Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Federal funding was no longer viable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tampa General Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 27 Nov 2024 (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.
The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are:
Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team?
Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigators will use a 1:1 allocation ratio of randomization to intervention and control. Randomization will be stratified by sex (male, female) and age (divided into 2 categories). Participants will be assigned to a randomization group upon completing the eligibility screener and consent has been obtained, which will occur after the patient has attended the Roundtable visit and completed baseline questionnaires, but before their first visit with the center.
| Arm | Type | Receives |
|---|---|---|
| AATAP (intervention) Arm | Experimental | Behavioral: AATAP interventionOne clinic visit with all transplant providers, racially concordant care team, dedicated social worked. This will incorporate: Cultural congruency, trust, health literacy and psychological support. Questionnaires also to be administered |
| Standard of Care (Control) Arm | No intervention | –Separate visits with nephologist, surgeons and social worker. This arm will follow common standard of care at the site. Questionnaires also to be administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- self-identify as Black or African American;
- 18 to 75 years of age
- have an eGFR < 20 or End Stage Renal Disease Diagnosis;
- screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns);
- medically eligible to begin transplant evaluation process determined by transplant team
Key exclusion criteria (5 listed)
- other racial groups
- participants who have previously received a transplant;
- pregnant women;
- participants who screen negative on the screener;
- children less than 18 years old
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 |
|---|---|---|
| AATAP interventionAATAP is a program created to address the barriers that Black patients face when accessing transplantation. AATAP providers resources in cultural congruency, trust, psychosocial support, and health literacy to provide patients with the individualized support needed to access the kidney transplant waitlist | Behavioural | AATAP (intervention) Arm |
Primary outcome
Listing status for each Arm by month 12
Time frame: 12 months from time of enrollment
Listing (active or inactive) status by month 12
3 secondary outcomes
Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale
Time frame: at enrollment and at 12 months after enrollment
Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)
Time frame: at enrollment and at 12 months after enrollment
trust in care received by transplant team using Adapted Trust in Physicians Scale
Time frame: at enrollment and at 12 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- 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.
Daniela Ladner, MD, MPH, FACS, FAST principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AATAP intervention in people with Kidney Transplant and ESRD (End Stage Renal Disease), run by Northwestern University 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: withdrawn, as of the sponsor's last update on 9 May 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 was withdrawn before enrolling participants, so there are no results.
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?
Listing status for each Arm by month 12 (time frame: 12 months from time of enrollment). 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 9 May 2025.