Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease

Purdue University

Status

Unknown

Conditions

Chronic Kidney Disease Mineral and Bone Disorder

Treatments

Other: Phosphorus Absorption Test

Study type

Observational

Funder types

Other

Identifiers

NCT03108222

1612460566

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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