Trial · NCT01077284

Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones

NCT01077284, Phase 2, Completed, Takeda; results first posted 2013-02-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones. Trials, record NCT01077284. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01077284

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Febuxostat Versus Allopurinol or Placebo in Patients With Hyperuricosuria and Calcium Oxalate Stones
NCT number: NCT01077284
Status: Completed
Phases: Phase 2
Enrollment: 99 participants, actual
Lead sponsor: Takeda
Conditions: Hyperuricosuria, Kidney Stones
Interventions: Febuxostat, Allopurinol, Placebo
First posted: 2010-03-01
Last updated: 2013-02-15
Results first posted: 2013-02-15

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion	Baseline and Month 6	The change from Baseline to Month 6 in 24-hour urine uric acid is expressed as a percentage of the Baseline uUA value.
Secondary	Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone	Baseline and Month 6	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.
Secondary	Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Baseline and Month 6	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.
Secondary	Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance	Baseline and Month 6	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).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion	Baseline and Month 6	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.	percent change	MEAN
SECONDARY	Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone	Baseline and Month 6	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.	percent change	MEAN
SECONDARY	Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Baseline and Month 6	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.	stones	MEAN
SECONDARY	Change From Baseline to Month 6 in 24-hour Measured Creatinine Clearance	Baseline and Month 6	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.	mL/min/1.73m²	MEAN

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion	Febuxostat		-58.6	Standard Deviation 28.56	percent change
Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion	Allopurinol		-36.4	Standard Deviation 36.97	percent change
Percent Change From Baseline to Month 6 in 24-hour Urine Uric Acid (uUA) Excretion	Placebo		-12.7	Standard Deviation 28.81	percent change
Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone	Febuxostat		-6.50	Standard Deviation 28.357	percent change
Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone	Allopurinol		0.63	Standard Deviation 12.605	percent change
Percent Change From Baseline to Month 6 in the In-plane Diameter of the Largest Calcium Oxalate (CaOx) Stone	Placebo		3.20	Standard Deviation 23.697	percent change
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Febuxostat	Baseline (n=28, 24, 30)	4.84	Standard Deviation 3.921	stones
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Allopurinol	Baseline (n=28, 24, 30)	6.60	Standard Deviation 6.832	stones
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Placebo	Baseline (n=28, 24, 30)	5.57	Standard Deviation 5.785	stones
Change From Baseline to Month 6 in the Number of Calcium Oxalate Stones	Febuxostat	Change from Baseline (n=26, 23, 26)	-0.06	Standard Deviation 1.602	stones

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Febuxostat	33
Overall Study	STARTED	Allopurinol	33
Overall Study	STARTED	Placebo	33
Overall Study	COMPLETED	Febuxostat	28
Overall Study	COMPLETED	Allopurinol	28
Overall Study	COMPLETED	Placebo	30
Overall Study	NOT COMPLETED	Febuxostat	5
Overall Study	NOT COMPLETED	Allopurinol	5
Overall Study	NOT COMPLETED	Placebo	3

Source ClinicalTrials.gov

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Back pain	Musculoskeletal and connective tissue disorders	Febuxostat	1	33
other	Back pain	Musculoskeletal and connective tissue disorders	Allopurinol	3	33
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	1	33
other	Flank pain	Musculoskeletal and connective tissue disorders	Febuxostat	4	33
other	Flank pain	Musculoskeletal and connective tissue disorders	Allopurinol	0	33
other	Flank pain	Musculoskeletal and connective tissue disorders	Placebo	2	33
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Febuxostat	1	33
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Allopurinol	2	33
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Placebo	0	33
other	Upper respiratory tract infection	Infections and infestations	Febuxostat	0	33

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Febuxostat
Total, all-cause mortality	Allopurinol
Total, all-cause mortality	Placebo
Total, other adverse events	Febuxostat	14	33
Total, other adverse events	Allopurinol	13	33
Total, other adverse events	Placebo	12	33
Total, serious adverse events	Febuxostat	0	33
Total, serious adverse events	Allopurinol	0	33
Total, serious adverse events	Placebo	1	33

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23929928	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01077284

GET https://conductscience.org/api/trials/v1/NCT01077284/events?page=2

API reference For AI assistants