Community-Based Screening for Chronic Kidney Disease

NCT07747363 | Completed

• 1 other identifier: L-INTMED-104588
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Kidney Disease; Hypertension

Keywords

urine albumin; chronic kidney disease; hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (1)

• Diastolic blood pressure change

  12 months

Study Arms (2)

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.

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.

Other: outpatient clinic kidney-protective care

Interventions

outpatient clinic kidney-protective care OTHER

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

Accepted kidney-protective care (Accepted); Declined kidney-protective care (Declined)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily attending community-based (typically a church) health fair;
• 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.

You may not qualify if:

• Symptoms of chronic disease (e.g., shortness of breath, chest pain, fatigue poor appetite
• Known kidney disease
• current smoker
• unable to provide informed consent.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Medical School - The University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Donald E Wesson, MD, MBA

  Dell Medical School - The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 5, 2026
• Study Start: June 21, 2006
• Primary Completion: December 15, 2011
• Study Completion: May 10, 2024
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available for one year after the first peer reviewed publication from this study is made public.
• Access Criteria: Scientists and scientific investigators will have access to the indicated supporting information checked in this document upon written request to Principal Investigator.

Locations

US (1)