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New treatment option for Chronic Kidney Disease (Stage 3-4)
Official title Phosphate Assessment in Chronic Kidney Disease Patients Study
ClinicalTrials.gov ID: NCT07368946
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Pregnant, currently breastfeeding, or \<3 months postpartum
- Current dialysis or kidney transplant patient
- Current use of insulin or chemotherapy drugs
- Smokes cigarettes or uses e-cigarettes (vapes)
- Uses nicotine products or other recreational drugs
- Medical history of stroke or myocardial infarction (MI)
See the full eligibility criteria
- 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
- Pregnant, currently breastfeeding, or \<3 months postpartum
- Current dialysis or kidney transplant patient
- Current use of insulin or chemotherapy drugs
- Smokes cigarettes or uses e-cigarettes (vapes)
- Uses nicotine products or other recreational drugs
- 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...
- Current use of certain medications that directly alter phosphate levels (i.e., phosphate binders; phosphate supplements, irregular use of iron)
- Regular use of laxatives
- Hypo- or hyperphosphatemia (serum phosphate \ 4.6 mg/dl)
- Hypo- or hypercalcemia (serum calcium \ 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)
- Body weight less than \<110 lbs (due to risk for phlebotomy-induced anemia)
- Received a blood transfusion in the last four months
- 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
- 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 potassium diet
- On low phosphate diet
- Specific dietary restrictions (i.e. vegetarian, vegan, ketogenic, etc.)
- Food allergies including but not limited to milk, egg, soy, nuts, shellfish, and wheat or gluten
- Allergic to sodium phosphate
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.