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Chronic kidney disease (CKD) affects approximately 26 million Americans with many more at risk for disease development. Elevated serum phosphorus (P) and related abnormalities in P homeostasis due to progressive loss of kidney function are primary driving forces behind cardiovascular dysfunction and mortality in CKD patients. Intestinal P absorption is an critical aspect in P homeostasis but has been understudied, particularly in the early stages of CKD progression. This study aims to determine P absorption in patients with moderate CKD compared to healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Subjects | Healthy subjects, free of CKD |
| |
| Moderate CKD Subjects | Subjects with moderate-stage CKD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphorus Absorption Test | Other | Subjects will undergo a radiophosphorus (P-33) absorption test over two days, that will include an oral administration of P-33 on the 1st day of the test, and an IV administration of P-33 on the 2nd day of the test. P-33 activity from serial serum and urine collections will be determined by scintillation counting, and fractional phosphorus absorption calculated by kinetic modeling. |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Phosphorus Absorption | Radiophosphorus (P-33) activity determined by liquid scintillation counting in serum and urine after oral and IV administration will be used to determine fractional phosphate absorption. | Measured from serial blood draws over a 4-hour time frame |
| Measure | Description | Time Frame |
|---|---|---|
| Serum FGF23 | serum intact and c-terminal FGF23 | Measured from baseline measures and serial blood draws over a 4-hour time frame |
| Serum 1,25(OH)2D | serum 1,25-dihydroxyvitamin D |
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Inclusion:
Men and women ages 30-75 years old, any race
Moderate CKD, based on the last set of labs done in the past year, defined as:
Glomerular Filtration Rate (GFR) category G3a (eGFR 45-59 mL/min) with A2 or A3 albuminuria or proteinuria by positive dipstick or urine protein/creatinine ratio (UPCR); -or- G3b (eGFR 30-44 mL/min), with or without evidence of albuminuria (any A1-A3) or proteinuria. (Figure 1)
-or- Healthy control with no diagnosis or evidence of CKD
Female subjects must be post-menopausal, surgically sterile, or confirmed not pregnant by pregnancy test and not breastfeeding.
Subjects must be on stable doses of medications (except those noted in exclusion criteria) for at least 6 weeks prior to the study
Exclusion:
Plans to initiate dialysis within 6 months
Labs based on the last set done in the past year:
Hypercalcemia defined as serum calcium > 10.5 mg/dL
Hyperkalemic > 5.5 mg/dL Prescribed a phosphate binder medication
Small bowel resection, bariatric surgery. Medically unstable or poorly controlled hypertension, diabetes, or gastrointestinal disorders in the opinion of the physicians on the study team
Calcitriol, ergocalciferol, cholecalciferol, vitamin D analogs, calcimimetics, PTH analogues, calcium supplements, multivitamins/mineral and other medications that may alter phosphorus metabolism - must be off for at least 6 weeks prior to study
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Healthy subjects and subjects with moderate CKD will be recruited from the community.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University Nutrition Science Department | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34244325 | Derived | Stremke ER, Wiese GN, Moe SM, Wastney ME, Moorthi RN, Hill Gallant KM. Intestinal Phosphorus Absorption in Moderate CKD and Healthy Adults Determined Using a Radioisotopic Tracer. J Am Soc Nephrol. 2021 Aug;32(8):2057-2069. doi: 10.1681/ASN.2020091340. Epub 2021 Jul 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2021 | |
| Reset | May 14, 2021 | |
| Release | Sep 23, 2021 | |
| Reset | Oct 20, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2021 | May 14, 2021 | |||
| Sep 23, 2021 |
| ID | Term |
|---|---|
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| Measured from baseline measures and serial blood draws over a 4-hour time frame |
| Serum parathyroid hormone (PTH) | serum intact parathyroid hormone | Measured from baseline measures and serial blood draws over a 4-hour time frame |
| Serum phosphate | serum phosphate | Measured from baseline measures and serial blood draws over a 4-hour time frame |
| 24h Urine phosphate | 24h urine phosphate | measured from two, 24-hour urine collections |
| Oct 20, 2021 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |