Phosphate Assessment in Chronic Kidney Disease Patients Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07368946
Status
Recruiting
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Conditions

  • Chronic Kidney Disease (Stage 3-4)
  • Chronic Kidney Disease Mineral and Bone Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dietary Phosphorus Intake — DIETARY_SUPPLEMENT
    Dietary phosphorus intake of about 777 mg/day for 7 days, followed by an increase to about 1,277mg/day for another 7 days, and a further increase to about 1,777 mg/day for the subsequent 7 days. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. 1200 mg/day and 1700 mg/day phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg/day meals.

Study Details

The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability. Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability. This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.

Key Dates

Start date
May 9, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Chronic Kidney Disease Patients
    Participants with eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group
  • Active Comparator: Control Group
    Healthy participants without CKD eGFR ≥ 60 ml/min/1.73m2

Primary Outcome Measure

Change in serum phosphate levels [ Time Frame: Baseline, week 1, week 2, and week 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Alexandra Hartman
[email protected]
2146458294
Paola Lanza, MD
[email protected]
469-852-9550
Jing Chen, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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