| NCT ID | NCT05970341 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas at Austin |
| Condition | Chronic Kidney Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 330 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 330 participants in total. It began in 2023-12-06 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This two-arm, parallel randomized trial study will assess the efficacy of a 6-month (26 weeks) community-based program in reducing kidney injury (as Urine Albumin to Creatinine ratio, uACR), cardiovascular risk (as Hemoglobin A1C and blood pressure), mental health (as PHQ-8) and diet quality (as fruits and vegetables intake and Healthy Eating Index) in community-dwelling, low-income adults diagnosed with early chronic kidney disease (stages 2 or 3 and not on kidney replacement therapies) compared to educational materials and usual care alone.
Eligibility Criteria
Inclusion Criteria: * Adult (18 years of age or older) * Primary care visit at either one of the three partner clinics from Harris Health \[Smith Clinic, Harris Health Outpatient Center (located on the LBJ campus), or Martin Luther King Jr. Health Center (MLK)\] and a primary care patient within Harris Health System * Have had at least 1 visit in the past 18 months with prior history in the clinic (i.e., not first visit) * Diagnosis of CKD (Stage 2, 3a, and 3b) as defined by estimated Glomerular Filtration Rate (eGFR) ≥ 30 and \<90 mL/min/1.73 m2 OR CDK 1 or undiagnosed with urine Albumin Creatinine Ratio ≥ 30 mg/g * Within the past 12 months, the most current serum K+ ≤ 4.6 mEq/L * English or Spanish speaking * Ability to participate in the program at least 6 months * Ability to clean, prepare, refrigerate/freeze food products that are given to them * Have access to receive SMS text messages * Location of preferred produce bag delivery within an available delivery zone Exclusion Criteria: * CKD 4, ESRD or on dialysis. * Taking certain medications chronically (more than twice a week for 90 days) that may interfere with K+ metabolism (such as non-steroidal anti-inflammatory drugs (NSAIDs), as self-reported during enrollment screening * Taking mineralocorticoid receptor antagonists * Taking Warfarin * Diagnosis of any specific kidney conditions (such as polycystic kidney disease, glomerulonephritis, Lupus associated with Nephritis, Antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)) that would contraindicate study participation as determined by physician * Medical history of organ transplant that would contraindicate study participation as determined by physician * Received immunotherapy for primary or secondary kidney disease within 6 months prior to enrolment * Diagnostic of heart failure conditions Class IV in the New York Heart Association (NYHA) functional classification * Had myocardial infarction, unstable angina, stroke, or transient ischemic attack (TIA) within 12 weeks prior to enrolment * Had coronary revascularization (PCI, CABG) or valvular repair within 12 weeks prior to enrolment * On active hospice care as self-reported during enrollment screening * Diagnosis of active malignancy requiring treatment that would contraindicate study participation as determined by physician * Has decompensated cirrhosis as determined by physician * Cognitive impairment that would contraindicate study participation as self-reported during enrollment screening
Contact & Investigator
Maninder Kahlon, PhD
PRINCIPAL INVESTIGATOR
University of Texas at Austin
Frequently Asked Questions
Who can join the NCT05970341 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Kidney Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05970341 currently recruiting?
Yes, NCT05970341 is actively recruiting participants. Contact the research team at Courtney.Mulligan@austin.utexas.edu for enrollment information.
Where is the NCT05970341 trial being conducted?
This trial is being conducted at Houston, United States, Houston, United States, Houston, United States.
Who is sponsoring the NCT05970341 clinical trial?
NCT05970341 is sponsored by University of Texas at Austin. The principal investigator is Maninder Kahlon, PhD at University of Texas at Austin. The trial plans to enroll 330 participants.
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