Trial Outcomes & Findings for Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones (NCT NCT00381849)
NCT ID: NCT00381849
Last Updated: 2016-02-04
Results Overview
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
COMPLETED
PHASE1/PHASE2
20 participants
baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment
2016-02-04
Participant Flow
Patients with recurring and analytically confirmed kidney stones were recruited from the Mayo Stone Clinic in Rochester, MN.
Participant milestones
| Measure |
Calcium Stone Subjects
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Wash Out
STARTED
|
10
|
10
|
|
Wash Out
COMPLETED
|
10
|
9
|
|
Wash Out
NOT COMPLETED
|
0
|
1
|
|
Second Intervention
STARTED
|
10
|
9
|
|
Second Intervention
COMPLETED
|
10
|
9
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
|
Open-label
STARTED
|
10
|
9
|
|
Open-label
COMPLETED
|
10
|
9
|
|
Open-label
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Calcium Stone Subjects
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
Wash Out
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones
Baseline characteristics by cohort
| Measure |
Calcium Stone Subjects
n=10 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
n=10 Participants
Subjects with confirmed cystine kidney stone(s)
|
Total
n=20 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
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatmentPopulation: CaOx was not analyzed for the Cystine Stone subjects.
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Outcome measures
| Measure |
Calcium Stone Subjects
n=10 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
CaOx at Baseline
|
1.83 KJoules/mol
Standard Deviation 0.28
|
—
|
|
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
CaOx after placebo (6 wks)
|
1.83 KJoules/mol
Standard Deviation 0.42
|
—
|
|
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
CaOx after Cystone (6 wks)
|
1.87 KJoules/mol
Standard Deviation 0.43
|
—
|
|
24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
CaOx at end of Cystone (46 weeks)
|
1.78 KJoules/mol
Standard Deviation 0.47
|
—
|
PRIMARY outcome
Timeframe: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatmentPopulation: Brushite was not analyzed for the Cystine Stone subjects.
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Outcome measures
| Measure |
Calcium Stone Subjects
n=10 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Brushite at Baseline
|
0.35 KJoules/mol
Standard Deviation 1.04
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Brushite after placebo (6 wks)
|
0.73 KJoules/mol
Standard Deviation 0.83
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Brushite after Cystone (6 wks)
|
0.38 KJoules/mol
Standard Deviation 0.98
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Brushite at end of Cystone (46 weeks)
|
0.09 KJoules/mol
Standard Deviation 1.29
|
—
|
PRIMARY outcome
Timeframe: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatmentPopulation: Hydroxyapatite was not analyzed for the Cystine Stone subjects.
Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
Outcome measures
| Measure |
Calcium Stone Subjects
n=10 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Hydroxyapatite at Baseline
|
4.25 KJoules/mol
Standard Deviation 2.02
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Hydroxyapatite after placebo (6 wks)
|
5.03 KJoules/mol
Standard Deviation 1.23
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Hydroxyapatite after Cystone (6 wks)
|
4.65 KJoules/mol
Standard Deviation 1.86
|
—
|
|
24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Hydroxyapatite at end of Cystone (46 weeks)
|
4.09 KJoules/mol
Standard Deviation 2.06
|
—
|
PRIMARY outcome
Timeframe: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatmentPopulation: Cystine excretion was not applicable to the Calcium Stone subjects.
Outcome measures
| Measure |
Calcium Stone Subjects
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
n=10 Participants
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
24 Hour Urinary Cystine Excretion
Cystine at Baseline
|
—
|
2770 mcmol/24 hours
Standard Deviation 947
|
|
24 Hour Urinary Cystine Excretion
Cystine after placebo (6 wks)
|
—
|
3183 mcmol/24 hours
Standard Deviation 1898
|
|
24 Hour Urinary Cystine Excretion
Cystine after Cystone (6 wks)
|
—
|
2948 mcmol/24 hours
Standard Deviation 2021
|
|
24 Hour Urinary Cystine Excretion
Cystine at end of Cystone (46 weeks)
|
—
|
4140 mcmol/24 hours
Standard Deviation 2398
|
PRIMARY outcome
Timeframe: Baseline, approximately 52 weeks after baselinePopulation: One subject was excluded from CT analysis because of bilateral stone removal surgery during the study
Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Outcome measures
| Measure |
Calcium Stone Subjects
n=9 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
n=10 Participants
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
Stone Density as Measured by Agatston Score Via Computerized Tomography
Baseline Right Kidney Agatston Score
|
49.75 Agatston Score
Standard Deviation 60.24
|
2,107 Agatston Score
Standard Deviation 4,417
|
|
Stone Density as Measured by Agatston Score Via Computerized Tomography
52 week Right Kidney Agatston Score
|
56.13 Agatston Score
Standard Deviation 74.23
|
2,183 Agatston Score
Standard Deviation 4,157
|
|
Stone Density as Measured by Agatston Score Via Computerized Tomography
Baseline Left Kidney Agatston Score
|
166.13 Agatston Score
Standard Deviation 143.16
|
383 Agatston Score
Standard Deviation 560
|
|
Stone Density as Measured by Agatston Score Via Computerized Tomography
52 week Left Kidney Agatston Score
|
247.71 Agatston Score
Standard Deviation 371.46
|
1,801 Agatston Score
Standard Deviation 2,741
|
PRIMARY outcome
Timeframe: Baseline, approximately 52 weeks after baselinePopulation: One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.
Measurement of kidney stone volume in cubic millimeters.
Outcome measures
| Measure |
Calcium Stone Subjects
n=9 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
n=10 Participants
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
Volume of Kidney Stones as Measured on Computerized Tomography
52 Week Right Kidney Stone Volume
|
52.75 mm^3
Standard Deviation 66.44
|
1,677 mm^3
Standard Deviation 3,139
|
|
Volume of Kidney Stones as Measured on Computerized Tomography
Baseline Left Kidney Stone Volume
|
141.25 mm^3
Standard Deviation 198.98
|
301 mm^3
Standard Deviation 422
|
|
Volume of Kidney Stones as Measured on Computerized Tomography
Baseline Right Kidney Stone Volume
|
45.5 mm^3
Standard Deviation 52.03
|
1,602 mm^3
Standard Deviation 3,335
|
|
Volume of Kidney Stones as Measured on Computerized Tomography
52 Week Left Kidney Stone Volume
|
174.25 mm^3
Standard Deviation 265.73
|
2,064 mm^3
Standard Deviation 688
|
SECONDARY outcome
Timeframe: Baseline, approximately 52 weeks after baselinePopulation: One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.
Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
Outcome measures
| Measure |
Calcium Stone Subjects
n=9 Participants
Subjects with confirmed calcium kidney stone(s)
|
Cystine Stone Subjects
n=9 Participants
Subjects with confirmed cystine kidney stone(s)
|
|---|---|---|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Left kidney stone burden increased
|
6 Kidneys
|
5 Kidneys
|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Left kidney stone burden decreased
|
1 Kidneys
|
2 Kidneys
|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Right kidney no change in stone burden
|
6 Kidneys
|
7 Kidneys
|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Right kidney stone burden increased
|
2 Kidneys
|
2 Kidneys
|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Right kidney stone burden decreased
|
1 Kidneys
|
0 Kidneys
|
|
Change in Stone Burden as Assessed by Radiologist at One Year
Left kidney no change in stone burden
|
2 Kidneys
|
2 Kidneys
|
Adverse Events
Calcium Stone Subjects
Cystine Stone Subjects
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