Trial Outcomes & Findings for Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones (NCT NCT01077284)
NCT ID: NCT01077284
Last Updated: 2013-02-15
Results Overview
The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2013-02-15
Participant Flow
Participants took part in the study at 24 investigative sites in the United States from 12 February 2010 to 21 November 2011.
Participants with hyperuricosuria and calcium oxalate stones were randomized to 1 of 3 treatment groups in a 1:1:1 ratio to receive placebo, allopurinol or febuxostat.
Participant milestones
| Measure |
Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
28
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
3
|
Reasons for withdrawal
| Measure |
Febuxostat
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
Baseline characteristics by cohort
| Measure |
Febuxostat
n=33 Participants
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=33 Participants
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=33 Participants
Placebo-matching capsules, orally, once daily for up to 6 months.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Body mass index categories
25 to <30 kg/m^2
|
8 participants
n=99 Participants
|
14 participants
n=107 Participants
|
7 participants
n=206 Participants
|
29 participants
n=7 Participants
|
|
Body mass index categories
≥30 kg/m^2
|
23 participants
n=99 Participants
|
18 participants
n=107 Participants
|
24 participants
n=206 Participants
|
65 participants
n=7 Participants
|
|
Age Continuous
|
49.1 years
STANDARD_DEVIATION 9.69 • n=99 Participants
|
46.5 years
STANDARD_DEVIATION 9.95 • n=107 Participants
|
46.5 years
STANDARD_DEVIATION 11.54 • n=206 Participants
|
47.4 years
STANDARD_DEVIATION 10.39 • n=7 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
85 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 participants
n=99 Participants
|
8 participants
n=107 Participants
|
3 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic and Latino
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
30 participants
n=206 Participants
|
80 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
4 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
26 participants
n=99 Participants
|
31 participants
n=107 Participants
|
29 participants
n=206 Participants
|
86 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=99 Participants
|
33 participants
n=107 Participants
|
33 participants
n=206 Participants
|
99 participants
n=7 Participants
|
|
Height
|
172.6 cm
STANDARD_DEVIATION 12.67 • n=99 Participants
|
176.5 cm
STANDARD_DEVIATION 7.71 • n=107 Participants
|
174.3 cm
STANDARD_DEVIATION 9.31 • n=206 Participants
|
174.5 cm
STANDARD_DEVIATION 10.14 • n=7 Participants
|
|
Weight
|
98.0 kg
STANDARD_DEVIATION 18.17 • n=99 Participants
|
100.9 kg
STANDARD_DEVIATION 20.13 • n=107 Participants
|
100.8 kg
STANDARD_DEVIATION 20.23 • n=206 Participants
|
99.9 kg
STANDARD_DEVIATION 19.38 • n=7 Participants
|
|
Body mass index (BMI)
|
32.9 kg/m^2
STANDARD_DEVIATION 5.71 • n=99 Participants
|
32.3 kg/m^2
STANDARD_DEVIATION 5.82 • n=107 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 6.29 • n=206 Participants
|
32.8 kg/m^2
STANDARD_DEVIATION 5.89 • n=7 Participants
|
|
Body mass index categories
18.5 to <25 kg/m^2
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Baseline Serum Urate
|
6.2 mg/dL
STANDARD_DEVIATION 1.63 • n=99 Participants
|
6.3 mg/dL
STANDARD_DEVIATION 1.49 • n=107 Participants
|
6.3 mg/dL
STANDARD_DEVIATION 1.24 • n=206 Participants
|
6.3 mg/dL
STANDARD_DEVIATION 1.45 • n=7 Participants
|
|
Baseline Serum Urate categories
<9.0 mg/dL
|
31 participants
n=99 Participants
|
31 participants
n=107 Participants
|
32 participants
n=206 Participants
|
94 participants
n=7 Participants
|
|
Baseline Serum Urate categories
9.0 to <10 mg/dL
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Baseline Serum Urate categories
≥10 mg/dL
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
Renal history
Moderately impaired
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
|
Renal history
Mildly impaired
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Renal history
Normal
|
31 participants
n=99 Participants
|
33 participants
n=107 Participants
|
32 participants
n=206 Participants
|
96 participants
n=7 Participants
|
|
24-hour urine uric acid
|
1000.6 mg/24 hours
STANDARD_DEVIATION 223.99 • n=99 Participants
|
948.1 mg/24 hours
STANDARD_DEVIATION 231.16 • n=107 Participants
|
909.4 mg/24 hours
STANDARD_DEVIATION 166.43 • n=206 Participants
|
952.7 mg/24 hours
STANDARD_DEVIATION 210.44 • n=7 Participants
|
|
24-hour urine uric acid categories
≤820 mg/24 hours (T1)
|
9 participants
n=99 Participants
|
13 participants
n=107 Participants
|
11 participants
n=206 Participants
|
33 participants
n=7 Participants
|
|
24-hour urine uric acid categories
>820 to ≤987 mg/24 hours
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
14 participants
n=206 Participants
|
32 participants
n=7 Participants
|
|
24-hour urine uric acid categories
>987 mg/24 hours (T2)
|
15 participants
n=99 Participants
|
11 participants
n=107 Participants
|
8 participants
n=206 Participants
|
34 participants
n=7 Participants
|
|
24-hour urinary calcium
|
240.1 mg/24 hours
STANDARD_DEVIATION 84.08 • n=99 Participants
|
297.9 mg/24 hours
STANDARD_DEVIATION 77.60 • n=107 Participants
|
278.7 mg/24 hours
STANDARD_DEVIATION 99.62 • n=206 Participants
|
272.2 mg/24 hours
STANDARD_DEVIATION 90.00 • n=7 Participants
|
|
Lifetime kidney stone episodes
|
8.8 kidney stone episodes
STANDARD_DEVIATION 10.18 • n=99 Participants
|
12.5 kidney stone episodes
STANDARD_DEVIATION 19.72 • n=107 Participants
|
11.3 kidney stone episodes
STANDARD_DEVIATION 14.97 • n=206 Participants
|
10.9 kidney stone episodes
STANDARD_DEVIATION 15.38 • n=7 Participants
|
|
Kidney stone passage
No
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
4 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Kidney stone passage
Yes
|
27 participants
n=99 Participants
|
33 participants
n=107 Participants
|
29 participants
n=206 Participants
|
89 participants
n=7 Participants
|
|
Composition of most recent passed stone
Calcium Oxalate
|
8 participants
n=99 Participants
|
14 participants
n=107 Participants
|
13 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Composition of most recent passed stone
Uric acid
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Composition of most recent passed stone
Calcium citrate
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Composition of most recent passed stone
Unknown
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
15 participants
n=206 Participants
|
52 participants
n=7 Participants
|
|
Kidney stone procedures
None
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
18 participants
n=206 Participants
|
44 participants
n=7 Participants
|
|
Kidney stone procedures
Shock Wave Lithotripsy
|
17 participants
n=99 Participants
|
20 participants
n=107 Participants
|
14 participants
n=206 Participants
|
51 participants
n=7 Participants
|
|
Kidney stone procedures
Ureteroscopy
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
24 participants
n=7 Participants
|
|
Kidney stone procedures
Nephrolithotomy/Nephrolithotripsy
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Kidney stone procedures
Open surgery
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
6 participants
n=7 Participants
|
|
Kidney stone procedures
Other procedure
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
2 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Kidney stone procedures
Stone Procedure
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
15 participants
n=206 Participants
|
55 participants
n=7 Participants
|
|
Use of kidney stone drug
None
|
28 participants
n=99 Participants
|
30 participants
n=107 Participants
|
30 participants
n=206 Participants
|
88 participants
n=7 Participants
|
|
Use of kidney stone drug
Allopurinol
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Use of kidney stone drug
Other drug therapy
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Baseline in-plane Diameter of the largest Calcium Oxalate Stone
|
12.24 mm
STANDARD_DEVIATION 7.363 • n=99 Participants
|
9.34 mm
STANDARD_DEVIATION 4.311 • n=107 Participants
|
8.22 mm
STANDARD_DEVIATION 3.756 • n=206 Participants
|
9.91 mm
STANDARD_DEVIATION 5.590 • n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: The full analysis set (patients who took at least 1 dose of double-blind study drug and had a baseline 24-hour uUA \>700 mg and at least 1 kidney CaOx stone ≥3 mm in its longest inplane diameter). Missing Month 6 values were imputed with baseline values if patient discontinued due to an AE; or otherwise with the last available post-baseline value.
The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.
Outcome measures
| Measure |
Febuxostat
n=33 Participants
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=33 Participants
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=33 Participants
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion
|
-58.6 percent change
Standard Deviation 28.56
|
-36.4 percent change
Standard Deviation 36.97
|
-12.7 percent change
Standard Deviation 28.81
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full analysis set, for whom Baseline and Month 6 MDCT data were available. Measurements more than 1-day after a patient's last dose of study drug were not included.
Multidetector Computed Tomography (MDCT) was used to visualize and measure calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader. The change from Baseline to month 6 is expressed as a percentage of the Baseline largest in-plane diameter.
Outcome measures
| Measure |
Febuxostat
n=27 Participants
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=24 Participants
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=29 Participants
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone
|
-6.50 percent change
Standard Deviation 28.357
|
0.63 percent change
Standard Deviation 12.605
|
3.20 percent change
Standard Deviation 23.697
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full analysis set for whom both Baseline and Month 6 MDCT data were available. Measurements more than 1 day after a patient's last dose of study drug were not included.
Multidetector Computed Tomography (MDCT) was used to visualize and count calcium oxalate kidney stones at Baseline and after 6 months of treatment. All MDCT images were analyzed independently by a Central Reader.
Outcome measures
| Measure |
Febuxostat
n=28 Participants
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=24 Participants
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=30 Participants
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones
Baseline (n=28, 24, 30)
|
4.84 stones
Standard Deviation 3.921
|
6.60 stones
Standard Deviation 6.832
|
5.57 stones
Standard Deviation 5.785
|
|
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones
Change from Baseline (n=26, 23, 26)
|
-0.06 stones
Standard Deviation 1.602
|
0.28 stones
Standard Deviation 1.953
|
0.10 stones
Standard Deviation 1.817
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Full analysis set. Missing Month 6 Visit 24-hour mCLcr values are imputed by Month 3 values if the Month 3 value was available otherwise the patient was excluded from the analysis.
Creatinine clearance is a measure of how well the kidneys are filtering creatinine, a waste product produced by the muscles. Measured creatinine clearance was calculated according to the following: Urine 24 hour Creatinine/Serum Creatinine x (total Urine volume/elapsed time) x (1.73/body surface area).
Outcome measures
| Measure |
Febuxostat
n=33 Participants
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=33 Participants
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=33 Participants
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance
Baseline (n=33, 33, 33)
|
146.9 mL/min/1.73m²
Standard Deviation 57.88
|
146.0 mL/min/1.73m²
Standard Deviation 44.32
|
147.1 mL/min/1.73m²
Standard Deviation 53.46
|
|
Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance
Change from Baseline (n=30, 29, 30)
|
-9.0 mL/min/1.73m²
Standard Deviation 60.82
|
-7.7 mL/min/1.73m²
Standard Deviation 83.28
|
-19.0 mL/min/1.73m²
Standard Deviation 45.72
|
Adverse Events
Febuxostat
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Allopurinol
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Febuxostat
n=33 participants at risk
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=33 participants at risk
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=33 participants at risk
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Febuxostat
n=33 participants at risk
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
|
Allopurinol
n=33 participants at risk
Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
|
Placebo
n=33 participants at risk
Placebo-matching capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
12.1%
4/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.1%
3/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Creatinine urine increased
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Urine calcium increased
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.1%
2/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.0%
1/33 • Treatment emergent AEs were defined as any AE, regardless of relationship to study drug, which occurred on or after the first double blind dose date and up to 30 days after the last dose date of the double-blind study drug (up to 7 months).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER