Chronic Kidney DiseaseNCT07747363
Community-Based Screening for Chronic Kidney Disease
A study testing outpatient clinic kidney-protective care in people with Chronic Kidney Disease and Hypertension, run by University of Texas at Austin at 1 site in United States.
Trial summary
Chronic Kidney Disease (CKD) incubates for years before kidney function declines to such low levels that patients develop symptoms and present for medical evaluation. The earlier in its course that CKD is identified, the more likely that medical care can slow or stop further worsening toward complete loss of kidney… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- outpatient clinic kidney-protective care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2006to 10 May 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily attending community-based (typically a church) health fair;
- 18-70 yrs old
- Without symptoms
- Has never been told to have chronic kidney disease (CKD) or other kidney-related conditions
- non-smoking (smoking is associated with increased urine albumin excretion)
- Able to provide informed consent.
Who cannot join
- Symptoms of chronic disease (e.g., shortness of breath, chest pain, fatigue poor appetite
- Known kidney disease
- current smoker
- unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dell Medical School - The University of Texas at Austin
Austin, Texas, 78712
About this study
Chronic Kidney Disease (CKD) incubates for years before kidney function declines to such low levels that patients develop symptoms and present for medical evaluation. The earlier in its course that CKD is identified, the more likely that medical care can slow or stop further worsening toward complete loss of kidney function, or end-stage kidney disease (ESKD). Individuals living in low income, largely minority communities are at greater risk for CKD than those in wealthier, non-minority communities but have historic mistrust of research. This project will conduct screening for high levels of a urine protein called albumin, indicating underlying CKD, in churches known to have the trust of communities, to identify asymptomatic individuals with CKD to be offered referral for kidney-protective medical care. Upon completion, this project will determine if individuals so identified with CKD will 1) accept referral for CKD care; 2) remain in care for at least 12 months; and 3) achieve a reduction in urine albumin levels, indicating CKD improvement. As such, this project will determine the value of community-based screening to reduce CKD prevalence.
Read the detailed description
The long-term objective of this study is to determine if community-based screening for chronic kidney disease (CKD) can 1) identify individuals with CKD in their lived environments; 2) lead to those identified with CKD accepting referral for kidney-protective medical care; and 3) sustain medical care long enough to achieve documented improvement of their CKD. Chronic kidney disease is increasing in incidence and prevalence, leading to increasing mortality from diseases for which CKD increases risk like cardiovascular disease (CVD), reduced quality of life associated with end-stage kidney disease (ESKD), and increasing economic costs of managing progressive CKD, particularly the ESKD costs of dialysis and kidney transplant. Unfortunately, CKD initiation and progression is asymptomatic until kidney function declines to very low levels at which patients present with symptoms to health systems for medical evaluation. Diagnosis of CKD is commonly made at its late stages when kidney-protective medical therapy is less effective. Kidney protective medical therapy is much more effective when instituted in early CKD stages so its early identification is critical. Because patients with CKD progress many years toward ESKD asymptomatically, it is best to identify them in their lived environments when they are in earlier stages at which kidney-protective medical care is most effective. Individuals living in low-income, largely minority communities, are at higher risk for CKD than those living in wealthier, non-minority communities. Because of historic mistreatment of these communities by the U.S. research and health system enterprises, many individuals in these communities harbor justified mistrust of the U.S. medical research and health system enterprise. Because of this mistrust, many individuals are less willing to participate in research studies and are less willing to accept referral for medical care even if they have been diagnosed with a condition that can be improved with medical care. The specific aims of this study are to determine if individuals from low-income, largely minority communities will 1) accept CKD screening done by dipstick measurement of urine albumin (mg)-to-creatinine (g) ratio (UACR); 2) accept outpatient clinic referral for kidney-protective medical care for those found to have CKD by high UACR (>30 mg/g); and 3) sustain clinic care for at least twelve months and achieve improved CKD as assessed by reduced UACR from baseline. Studies support that individuals from low-income, largely minority communities are more likely to accept and follow through on guidance received from community-based institutions with which they are familiar that have "trusted agency". Such institutions include churches in these communities that have earned the trust of the communities over many years. These churches often have medical ministries through which they conduct "health fairs" during which church members and non-church members from the surrounding communities come to learn health topics, learn about diseases common to their communities, and are offered the opportunity to be screened for some of these diseases. Studies also support that community members are more likely to accept and follow through on guidance from individuals from and/or with knowledge of their communities, even if these individuals are not traditional health professionals like physicians or nurses. We will employ trained community health workers (CHW) to be part of the research team, are from or familiar with these communities and so have the trust of the community, and who will conduct the screening under the supervision of the principal investigator. At a screened area of the church during a health fair a CHW will explain the study to attendees and if the attendee signs informed consent, the CHW will measure blood pressure and ask the attendee to provide at least 20 ml urine for UACR. If UACR is > 30 mg/g, it will be sent for laboratory confirmation. If confirmed, the attendee will be offered study enrollment and offered outpatient clinic referral to receive kidney-protective kidney care at no out of pocket cost. Those who agree to be enrolled will be included in the study whether they accept referral (experimental group) or decline (control group). All will be asked to return to the church in 12 months for repeat blood pressure and UACR measurement. Those with blood pressure >140/90 but UACR <30 mg/g will be offered outpatient clinic referral but will not be enrolled in the study.
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- outpatient clinic kidney-protective care
- Keywords
- urine albumin, chronic kidney disease, hypertension
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient clinic kidney-protective careOther
Participants in the Placebo Comparative group are those who decline outpatient referral for outpatient clinic kidney-protective medical care and so receive no medical care
| Study group | Role | What they receive |
|---|---|---|
| Accepted kidney-protective care (Accepted) | Experimental | Participants with UACR > 30 mg/g who accepted outpatient clinic referral for kidney-protective medical care and sustained such care for 12 months. Receives: Other: outpatient clinic kidney-protective care |
| Declined kidney-protective care (Declined) | Placebo comparator | Participants with UACR > 30 mg/g who declined outpatient clinic referral for kidney-protective medical care. Receives: Other: outpatient clinic kidney-protective care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuminuria change
Change in 12-month urine albumin (mg)-to-creatinine (g) ratio (UACR) compared with the baseline UACR measured at the same community-based setting at which screening for chronic kidney disease was done.
Measured: 12 months
Systolic blood pressure change
Change in 12-month systolic blood pressure compared with the baseline systolic blood pressure measured with an automated cuff with both measurements done at the same community-based setting at which screening for chronic kidney disease was done.
Measured: 12 months
Secondary outcomes (1)
Diastolic blood pressure change
Change in 12-month diastolic blood pressure compared with the baseline diastolic blood pressure measured with an automated cuff with both measurements done at the same community-based setting at which screening for chronic kidney disease was done.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start21 Jun 2006
- Primary completion15 Dec 2011
- Study completion10 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants attending local church health fairs will be screen for chronic kidney disease using measurement of blood pressure and urine albumin (mg)-to-creatinine (g) ratio (UACR). Guidelines indicate that those with UACR \> 30 mg/g have CKD. All those screened who are found to have UACR \> 30 mg/g will be offered outpatient clinic referral for kidney-protective medical care. Those who accept referral will be in the experimental group and those who decline referral will be in the control group. All participants with UACR \> 30 mg/g will be asked to return to the church at 12 months for repeat blood pressure and UACR. Those screen with blood pressure \>140/90 mm Hg but with UACR \<30 mg/g will receive outpatient clinic referral for blood pressure management but will not be included in this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Wesson, University of Texas at Austin
- Investigators
- Donald E Wesson, MD, MBA, Principal investigator, Dell Medical School - The University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747363
- Sponsor's protocol ID
- L-INTMED-104588
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon written request from scientists and scientific investigators, we will share deidentified individual participant data, the study protocol, informed consent form, and the statistical strategies used to analyze participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Screening for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07747363
- Acronym / sponsor ID
- L-INTMED-104588
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- urine albumin, chronic kidney disease, hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 21 Jun 2006 (actual)
- Primary completion
- 15 Dec 2011 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 5 Aug 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.
Chronic Kidney Disease (CKD) incubates for years before kidney function declines to such low levels that patients develop symptoms and present for medical evaluation. The earlier in its course that CKD is identified, the more likely that medical care can slow or stop further worsening toward complete loss of kidney function, or end-stage kidney disease (ESKD). Individuals living in low income, largely minority communities are at greater risk for CKD than those in wealthier, non-minority communities but have historic mistrust of research. This project will conduct screening for high levels of a urine protein called albumin, indicating underlying CKD, in churches known to have the trust of communities, to identify asymptomatic individuals with CKD to be offered referral for kidney-protective medical care. Upon completion, this project will determine if individuals so identified with CKD will 1) accept referral for CKD care; 2) remain in care for at least 12 months; and 3) achieve a reduction in urine albumin levels, indicating CKD improvement. As such, this project will determine the value of community-based screening to reduce CKD prevalence.
Detailed description
The long-term objective of this study is to determine if community-based screening for chronic kidney disease (CKD) can 1) identify individuals with CKD in their lived environments; 2) lead to those identified with CKD accepting referral for kidney-protective medical care; and 3) sustain medical care long enough to achieve documented improvement of their CKD. Chronic kidney disease is increasing in incidence and prevalence, leading to increasing mortality from diseases for which CKD increases risk like cardiovascular disease (CVD), reduced quality of life associated with end-stage kidney disease (ESKD), and increasing economic costs of managing progressive CKD, particularly the ESKD costs of dialysis and kidney transplant. Unfortunately, CKD initiation and progression is asymptomatic until kidney function declines to very low levels at which patients present with symptoms to health systems for medical evaluation. Diagnosis of CKD is commonly made at its late stages when kidney-protective medical therapy is less effective. Kidney protective medical therapy is much more effective when instituted in early CKD stages so its early identification is critical. Because patients with CKD progress many years toward ESKD asymptomatically, it is best to identify them in their lived environments when they are in earlier stages at which kidney-protective medical care is most effective. Individuals living in low-income, largely minority communities, are at higher risk for CKD than those living in wealthier, non-minority communities. Because of historic mistreatment of these communities by the U.S. research and health system enterprises, many individuals in these communities harbor justified mistrust of the U.S. medical research and health system enterprise. Because of this mistrust, many individuals are less willing to participate in research studies and are less willing to accept referral for medical care even if they have been diagnosed with a condition that can be improved with medical care. The specific aims of this study are to determine if individuals from low-income, largely minority communities will 1) accept CKD screening done by dipstick measurement of urine albumin (mg)-to-creatinine (g) ratio (UACR); 2) accept outpatient clinic referral for kidney-protective medical care for those found to have CKD by high UACR (>30 mg/g); and 3) sustain clinic care for at least twelve months and achieve improved CKD as assessed by reduced UACR from baseline. Studies support that individuals from low-income, largely minority communities are more likely to accept and follow through on guidance received from community-based institutions with which they are familiar that have "trusted agency". Such institutions include churches in these communities that have earned the trust of the communities over many years. These churches often have medical ministries through which they conduct "health fairs" during which church members and non-church members from the surrounding communities come to learn health topics, learn about diseases common to their communities, and are offered the opportunity to be screened for some of these diseases. Studies also support that community members are more likely to accept and follow through on guidance from individuals from and/or with knowledge of their communities, even if these individuals are not traditional health professionals like physicians or nurses. We will employ trained community health workers (CHW) to be part of the research team, are from or familiar with these communities and so have the trust of the community, and who will conduct the screening under the supervision of the principal investigator. At a screened area of the church during a health fair a CHW will explain the study to attendees and if the attendee signs informed consent, the CHW will measure blood pressure and ask the attendee to provide at least 20 ml urine for UACR. If UACR is > 30 mg/g, it will be sent for laboratory confirmation. If confirmed, the attendee will be offered study enrollment and offered outpatient clinic referral to receive kidney-protective kidney care at no out of pocket cost. Those who agree to be enrolled will be included in the study whether they accept referral (experimental group) or decline (control group). All will be asked to return to the church in 12 months for repeat blood pressure and UACR measurement. Those with blood pressure >140/90 but UACR <30 mg/g will be offered outpatient clinic referral but will not be enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants attending local church health fairs will be screen for chronic kidney disease using measurement of blood pressure and urine albumin (mg)-to-creatinine (g) ratio (UACR). Guidelines indicate that those with UACR > 30 mg/g have CKD. All those screened who are found to have UACR > 30 mg/g will be offered outpatient clinic referral for kidney-protective medical care. Those who accept referral will be in the experimental group and those who decline referral will be in the control group. All participants with UACR > 30 mg/g will be asked to return to the church at 12 months for repeat blood pressure and UACR. Those screen with blood pressure >140/90 mm Hg but with UACR <30 mg/g will receive outpatient clinic referral for blood pressure management but will not be included in this study.
| Arm | Type | Receives |
|---|---|---|
| Accepted kidney-protective care (Accepted) | Experimental | Other: outpatient clinic kidney-protective careParticipants with UACR > 30 mg/g who accepted outpatient clinic referral for kidney-protective medical care and sustained such care for 12 months. |
| Declined kidney-protective care (Declined) | Placebo comparator | Other: outpatient clinic kidney-protective careParticipants with UACR > 30 mg/g who declined outpatient clinic referral for kidney-protective medical care. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily attending community-based (typically a church) health fair;
- 18-70 yrs old
- Without symptoms
- Has never been told to have chronic kidney disease (CKD) or other kidney-related conditions
- non-smoking (smoking is associated with increased urine albumin excretion)
Key exclusion criteria (4 listed)
- Symptoms of chronic disease (e.g., shortness of breath, chest pain, fatigue poor appetite
- Known kidney disease
- current smoker
- unable to provide informed consent.
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 |
|---|---|---|
| outpatient clinic kidney-protective careParticipants in the Placebo Comparative group are those who decline outpatient referral for outpatient clinic kidney-protective medical care and so receive no medical care | Other | Accepted kidney-protective care (Accepted), Declined kidney-protective care (Declined) |
Primary outcome
Albuminuria change
Time frame: 12 months
Change in 12-month urine albumin (mg)-to-creatinine (g) ratio (UACR) compared with the baseline UACR measured at the same community-based setting at which screening for chronic kidney disease was done.
Systolic blood pressure change
Time frame: 12 months
Change in 12-month systolic blood pressure compared with the baseline systolic blood pressure measured with an automated cuff with both measurements done at the same community-based setting at which screening for chronic kidney disease was done.
1 secondary outcome
Diastolic blood pressure change
Time frame: 12 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 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Upon written request from scientists and scientific investigators, we will share deidentified individual participant data, the study protocol, informed consent form, and the statistical strategies used to analyze participant data.
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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.
Donald E Wesson, MD, MBA principal investigator
Dell Medical School - The University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient clinic kidney-protective care in people with Chronic Kidney Disease and Hypertension, run by University of Texas at Austin 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 6 inclusion and 4 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 6 Aug 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. Some participants in this study may receive a placebo. 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?
Albuminuria change (time frame: 12 months). The study lists 2 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 Aug 2026.