NCT07368946Recruiting
Phosphate Assessment in Chronic Kidney Disease Patients Study
A Pilot Feeding Study to Assess Phosphate Overload in Patients With Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 9 May 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT07368946
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 9 May 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current dialysis or kidney transplant patient
- Current use of insulin or chemotherapy drugs
- Uses nicotine products or other recreational drugs
- Current use of certain medications that directly alter phosphate levels (i.e., phosphate binders; phosphate supplements, irregular use of iron)
- Received a blood transfusion in the last four months
Other illness
- Medical history of stroke or myocardial infarction (MI)
- Medical history of conditions that can affect phosphate metabolism (i.e., uncontrolled thyroid disorder, parathyroid disorder, or gastrointestinal malabsorption disorders \[Crohn's, ulcerative colitis, and celiac disease\], cirrhosis)
- Extreme hypertension as demonstrated by a blood pressure \> 180/120 as the average of 3 blood pressures taken during the screening/baseline, or extremely low blood pressure \< 80/50
- Food allergies including but not limited to milk, egg, soy, nuts, shellfish, and wheat or gluten
Lab values
- Hypo- or hyperphosphatemia (serum phosphate \< 2.5 or \> 4.6 mg/dl)
- Hypo- or hypercalcemia (serum calcium \< 8.4 or \> 10.7 mg/dl)
- Severe anemia (hemoglobin \< 8 g/dl for women and \< 9 g/dl for men)
- Severe hyperglycemia (serum blood glucose \> 300 mg/dl)
- On low potassium diet
- Allergic to sodium phosphate
Other
- Pregnant, currently breastfeeding, or \<3 months postpartum
- Smokes cigarettes or uses e-cigarettes (vapes)
- Regular use of laxatives
- Body weight less than \<110 lbs (due to risk for phlebotomy-induced anemia)
- Unwilling or unable to eat study meals
- Lack of access to a functional refrigerator or freezer
- Lack of access to a microwave or conventional oven
- On low phosphate diet
- Specific dietary restrictions (i.e. vegetarian, vegan, ketogenic, etc.)
- Unable or unwilling to complete urinary sample collection or food diaries
- Unable or unwilling to provide informed consent
- Unable to read or speak English
- Participant in other conflict clinical trial
- Unable to complete the study measurements
- Unsafe to participate in this study per investigator's judgement
Who the study is looking for
- Men or women aged 18 years or older, of any race/ethnicity
- Women must either be post-menopausal or have no monthly menstrual cycle
- Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories
- eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group (CKD Stage 3 or Stage 4)
- eGFR ≥ 60 ml/min/1.73m2 and negative urine protein on dipstick test for the non-CKD group
- English speaking
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.