Trial Outcomes & Findings for Role Of Phosphorus And FGF 23 In Patients With Dent Disease (NCT NCT02016235)
NCT ID: NCT02016235
Last Updated: 2020-03-23
Results Overview
Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
baseline, day 7
Results posted on
2020-03-23
Participant Flow
Participant milestones
| Measure |
Dent Disease Intervention
Dent Disease subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Kidney Stone Subjects
Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Dent Disease Observation
Dent disease subjects will not get phosphorus
Observation: Baseline blood and urine measurements only
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dent Disease Intervention
n=10 Participants
Dent Disease subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Kidney Stone Subjects
n=10 Participants
Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Dent Disease Observation
n=10 Participants
Dent disease subjects will not get phosphorus
Observation: Baseline blood and urine measurements only
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 12.0 • n=10 Participants
|
55.3 years
STANDARD_DEVIATION 14.6 • n=10 Participants
|
10.2 years
STANDARD_DEVIATION 1.3 • n=10 Participants
|
30.6 years
STANDARD_DEVIATION 9.3 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
30 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: baseline, day 7Population: Data were not collected for the Disease Dent Observation Group
Urine protein tests detect and/or measure protein being released into the urine. Normal urine protein elimination is less than 150 mg/day
Outcome measures
| Measure |
Dent Disease Intervention
n=10 Participants
Dent Disease subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Kidney Stone Subjects
n=10 Participants
Kidney stone with or without phosphate leak subjects will receive 2 week supplementation with phosphorus
Phosphorus Supplement: 250 mg po qid
|
Dent Disease Observation
Dent disease subjects will not get phosphorus
Observation: Baseline blood and urine measurements only. Day 7 Urine total protein not obtained
|
|---|---|---|---|
|
Change in Urine Total Protein
|
1681 mg/day
Standard Deviation 979
|
59 mg/day
Standard Deviation 38
|
—
|
Adverse Events
Dent Disease Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Kidney Stone Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dent Disease Observation
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place