Trial Outcomes & Findings for Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease (NCT NCT04019379)

NCT ID: NCT04019379

Last Updated: 2024-09-19

Results Overview

Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Sequence A High Phos crossover to Low Phos High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium) Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)	Sequence B Low Phos crossover to High Phos Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium) High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Sequence A n=1 Participants High Phos crossover to Low Phos High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium) Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)	Sequence B n=2 Participants Low Phos crossover to High Phos Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium) High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	71 years n=5 Participants	52 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
estimated glomerular filtration rate (eGFR)	40 mL/min/1.73m^2 n=5 Participants	35 mL/min/1.73m^2 n=7 Participants	37 mL/min/1.73m^2 n=5 Participants
body mass index (BMI)	34.7 kg/m^2 n=5 Participants	20.5 kg/m^2 n=7 Participants	25.2 kg/m^2 n=5 Participants
Serum phosphorus	2.5 mg/dL n=5 Participants	2.7 mg/dL n=7 Participants	2.6 mg/dL n=5 Participants
Serum intact fibroblast growth factor-23 (iFGF23)	27.6 pg/mL n=5 Participants	78.3 pg/mL n=7 Participants	61.4 pg/mL n=5 Participants
Serum 1,25-dihydroxyvitamin D3 (1,25D)	46 pg/mL n=5 Participants	26 pg/mL n=7 Participants	32 pg/mL n=5 Participants
Serum intact parathyroid hormone (iPTH)	85.5 pg/mL n=5 Participants	154.7 pg/mL n=7 Participants	131.7 pg/mL n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Determined by kinetic modeling of serum and urine Ca-44 isotope after oral and IV isotope administrations

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Fractional Calcium Absorption	0.30 fraction of 1.00 Interval 0.22 to 0.45	0.42 fraction of 1.00 Interval 0.22 to 0.8

PRIMARY outcome

Timeframe: 48 hours

Determined by kinetic modeling of serum and urine P-33 isotope after oral and IV isotope administrations

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Fractional Phosphorus Absorption	0.73 fraction of 1.00 Interval 0.58 to 0.95	0.69 fraction of 1.00 Interval 0.51 to 0.91

PRIMARY outcome

Timeframe: 1 week

Determined by analysis of calcium content in complete 24-hour urine and stool collections, subtracted from the diet calcium content consumed. Values can be negative, zero, or positive.

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Calcium Balance	126 mg/d Interval -36.0 to 343.0	199 mg/d Interval 117.0 to 315.0

PRIMARY outcome

Timeframe: 1 weeks

Determined by analysis of phosphorus content in complete 24-hour urine and stool collections, subtracted from the diet phosphorus content consumed. Values can be negative, zero, or positive.

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Phosphorus Balance	65 mg/d Interval -292.0 to 481.0	73 mg/d Interval -144.0 to 416.0

SECONDARY outcome

Timeframe: Day 1-8

Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Serum Intact Fibroblast Growth Factor 23 (iFGF23)	67.9 pg/mL Interval 47.9 to 96.2	53.4 pg/mL Interval 44.1 to 68.6

SECONDARY outcome

Timeframe: Day 1-8

Determined by enzyme-linked immunoassay (ELISA). Values for each subject are an average of 6 serial measures taken during the 1 week balance period (between Days 1-8)

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Serum Intact Parathyroid Hormone (iPTH)	122.7 pg/mL Interval 101.2 to 136.2	104.7 pg/mL Interval 92.2 to 113.4

SECONDARY outcome

Timeframe: Day 1

Determined by LC-MS/MS. Values are from Day 1 of the metabolic balance period (following 1 week of acclimation to assigned study diet).

Outcome measures

Measure	High Phosphorus Diet n=3 Participants High Phosphorus Diet: Controlled research diet of high phosphorus (with low calcium)	Low Phosphorus Diet n=3 Participants Low Phosphorus Diet: Controlled research diet of low phosphorus (with low calcium)
Serum 1,25-dihydroxyvitamin D (1,25D)	29.7 pg/mL Interval 21.0 to 40.0	29.7 pg/mL Interval 17.0 to 41.0

Adverse Events

High Phosphorus Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Phosphorus Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathleen M. Hill Gallant, PhD

University of Minnesota

Phone: 612-625-5285

Email: hillkm@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place