Trial Outcomes & Findings for Treatment for Calcium Phosphate Kidney Stone Disease (NCT NCT01754779)
NCT ID: NCT01754779
Last Updated: 2024-04-04
Results Overview
This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
2 weeks
Results posted on
2024-04-04
Participant Flow
Out of 41 patients who met inclusion criteria and were contacted for study enrollment, a total of 13 subjects agreed to enroll and were consented and each participant was evaluated during 3 phases in randomized order.
Participant milestones
| Measure |
Placebo, Then Citric Acid, Then Potassium Citrate
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
|
Placebo, Then Potassium Citrate, Then Citric Acid
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
|
Potassium Citrate, Then Placebo, Then Citric Acid
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
|
Potassium Citrate, Then Citric Acid, Then Placebo
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
|
Citric Acid, Then Potassium Citrate, Then Placebo
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
|
Citric Acid, Then Placebo, Then Potassium Citrate
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
|
|---|---|---|---|---|---|---|
|
First Intervention (1 Week)
STARTED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
First Intervention (1 Week)
COMPLETED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
First Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Washout (1 Week)
COMPLETED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (1 Week)
STARTED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Second Intervention (1 Week)
COMPLETED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Second Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (1 Week)
STARTED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Third Intervention (1 Week)
COMPLETED
|
2
|
1
|
2
|
3
|
3
|
2
|
|
Third Intervention (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment for Calcium Phosphate Kidney Stone Disease
Baseline characteristics by cohort
| Measure |
Placebo, Then Citric Acid, Then Potassium Citrate
n=2 Participants
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
|
Placebo, Then Potassium Citrate, Then Citric Acid
n=1 Participants
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
|
Potassium Citrate, Then Placebo, Then Citric Acid
n=2 Participants
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
|
Potassium Citrate, Then Citric Acid, Then Placebo
n=3 Participants
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
|
Citric Acid, Then Potassium Citrate, Then Placebo
n=3 Participants
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
|
Citric Acid, Then Placebo, Then Potassium Citrate
n=2 Participants
Citric Acid: 3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
Placebo: 3 tablets twice daily of matching placebo during the placebo phase.
Potassium Citrate: 2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
34.8 years
n=7 Participants
|
49.2 years
STANDARD_DEVIATION 27.9 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 24.5 • n=4 Participants
|
45.6 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
35.6 years
STANDARD_DEVIATION 1.3 • n=8 Participants
|
41 years
STANDARD_DEVIATION 15 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
2 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
11 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
4 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
2 participants
n=8 Participants
|
8 participants
n=8 Participants
|
|
Height
|
1.66 metres
STANDARD_DEVIATION 0.13 • n=5 Participants
|
1.58 metres
n=7 Participants
|
1.56 metres
STANDARD_DEVIATION 0.02 • n=5 Participants
|
1.63 metres
STANDARD_DEVIATION 0.18 • n=4 Participants
|
1.69 metres
STANDARD_DEVIATION 0.06 • n=21 Participants
|
1.64 metres
STANDARD_DEVIATION 0.05 • n=8 Participants
|
1.63 metres
STANDARD_DEVIATION 0.10 • n=8 Participants
|
|
Weight
|
74.2 kg
STANDARD_DEVIATION 3.4 • n=5 Participants
|
89.0 kg
n=7 Participants
|
70.3 kg
STANDARD_DEVIATION 18.0 • n=5 Participants
|
56.7 kg
STANDARD_DEVIATION 16.0 • n=4 Participants
|
91.4 kg
STANDARD_DEVIATION 11.0 • n=21 Participants
|
53.8 kg
STANDARD_DEVIATION 7.4 • n=8 Participants
|
71.6 kg
STANDARD_DEVIATION 18.5 • n=8 Participants
|
|
Body mass index (BMI)
|
26.9 kg/m^2
STANDARD_DEVIATION 2.8 • n=5 Participants
|
35.9 kg/m^2
n=7 Participants
|
28.9 kg/m^2
STANDARD_DEVIATION 8.0 • n=5 Participants
|
21.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=4 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 2.1 • n=21 Participants
|
20.2 kg/m^2
STANDARD_DEVIATION 4.0 • n=8 Participants
|
26.7 kg/m^2
STANDARD_DEVIATION 6.4 • n=8 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThis variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.
Outcome measures
| Measure |
Placebo
n=13 Participants
Placebo tablets twice daily
Placebo: Matching placebo for both aims.
|
Citric Acid
n=13 Participants
Citric acid tablets twice daily
Citric Acid
|
Potassium Citrate
n=13 Participants
Potassium Citrate tablets twice daily
Potassium Citrate
|
|---|---|---|---|
|
Urinary Calcium Phosphate Saturation
|
2.38 no units
Standard Deviation 1.07
|
1.97 no units
Standard Deviation 0.75
|
2.19 no units
Standard Deviation 0.96
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Citric Acid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Potassium Citrate
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