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

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ClinicalTrials.gov Identifier: NCT03108222
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Kathleen Hill Gallant, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Mineral and Bone Disorder Other: Phosphorus Absorption Test

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Phosphorus Absorption in Healthy Adults and in Patients With Moderate Chronic Kidney Disease
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Phosphorus

Group/Cohort Intervention/treatment
Healthy Subjects
Healthy subjects, free of CKD
Other: Phosphorus Absorption Test
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.

Moderate CKD Subjects
Subjects with moderate-stage CKD
Other: Phosphorus Absorption Test
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.




Primary Outcome Measures :
  1. Fractional Phosphorus Absorption [ Time Frame: Measured from serial blood draws over a 4-hour time frame ]
    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.


Secondary Outcome Measures :
  1. Serum FGF23 [ Time Frame: Measured from baseline measures and serial blood draws over a 4-hour time frame ]
    serum intact and c-terminal FGF23

  2. Serum 1,25(OH)2D [ Time Frame: Measured from baseline measures and serial blood draws over a 4-hour time frame ]
    serum 1,25-dihydroxyvitamin D

  3. Serum parathyroid hormone (PTH) [ Time Frame: Measured from baseline measures and serial blood draws over a 4-hour time frame ]
    serum intact parathyroid hormone

  4. Serum phosphate [ Time Frame: Measured from baseline measures and serial blood draws over a 4-hour time frame ]
    serum phosphate

  5. 24h Urine phosphate [ Time Frame: measured from two, 24-hour urine collections ]
    24h urine phosphate



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy subjects and subjects with moderate CKD will be recruited from the community.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108222


Contacts
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Contact: Kathleen Hill Gallant, PhD 765-494-0101 hillgallant@purdue.edu
Contact: Elizabeth Stremke, BS 765-494-0385 estremke@purdue.edu

Locations
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United States, Indiana
Purdue University Nutrition Science Department Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Kathleen Hill Gallant, PhD    765-494-0101    hillgallant@purdue.edu   
Contact: Elizabeth Stremke, BS    765-494-0385    estremke@purdue.edu   
Sponsors and Collaborators
Purdue University

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Responsible Party: Kathleen Hill Gallant, Principal Investigator, Purdue University
ClinicalTrials.gov Identifier: NCT03108222     History of Changes
Other Study ID Numbers: 1612460566
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kathleen Hill Gallant, Purdue University:
chronic kidney disease
CKD
renal failure
phosphorus
phosphate
intestinal absorption

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Bone Diseases
Chronic Kidney Disease-Mineral and Bone Disorder
Urologic Diseases
Renal Insufficiency
Musculoskeletal Diseases
Rickets
Bone Diseases, Metabolic
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases