Trial Outcomes & Findings for Racial Differences in Phosphorus Metabolism (NCT NCT00856726)

NCT ID: NCT00856726

Last Updated: 2017-09-11

Results Overview

Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 26 participants
• Primary outcome timeframe: six hours
• Results posted on: 2017-09-11

Participant Flow

Participant milestones

Measure	PTH Infusion (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Racial Differences in Phosphorus Metabolism

Baseline characteristics by cohort

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	36 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: six hours

Fractional excretion of phosphorus (the fraction of phosphorus filtered by the kidney which is excreted in the urine)

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Urinary Phosphorus Excretion	11 percentage of fractional excretion Standard Deviation 0.5

SECONDARY outcome

Timeframe: six hours

Population: adult volunteers

The change in fibroblast growth factor 23 concentrations from baseline to six hours

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Fibroblast Growth Factor 23	10 relative units (RU)/ml Standard Deviation 10

SECONDARY outcome

Timeframe: six hours

Population: adult volunteers

change in serum phosphorus from baseline to six hours

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Serum Phosphorus	0.4 mg/dL Standard Deviation 0.1

SECONDARY outcome

Timeframe: six hours

Population: adult volunteers

change in serum calcium from baseline to six hours

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Serum Calcium	0.4 mg/dL Standard Deviation 0.2

SECONDARY outcome

Timeframe: six hours

Population: adult volunteers

change in parathyroid hormone from baseline to six hours

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Parathyroid Hormone	9 pg/ml Standard Deviation 3

SECONDARY outcome

Timeframe: six hours

Population: adult volunteers

change in urinary fractional excretion of calcium from baseline to six hours

Outcome measures

Measure	PTH Infusion n=26 Participants (1-34) PTH infusion at a rate of 0.055 ug/kg/hour for six hours 1-34 parathyroid infusion: 1-34 parathyroid infusion at 0.055 mcg/kg/hr for 6 hours
Fractional Excretion of Calcium	0.25 percentage of fractional excretion Standard Deviation 0.05

Adverse Events

PTH Infusion

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

Orlando Gutierrez

University of Alabama at Birmingham

Phone: 205-996-2736

Email: ogutierrez@uabmc.edu

Results disclosure agreements

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