Overview

This trial is active, not recruiting.

Condition hyperuricemia
Treatment febuxostat
Sponsor Freed Study Group
Collaborator Teijin Pharma
Start date November 2013
End date October 2017
Trial size 1000 participants
Trial identifier NCT01984749, 0078, UMIN000012134

Summary

The purpose of this study is to demonstrate the effect of febuxostat in preventing cerebral and cardiorenovascular events in elderly patients with hyperuricemia who are at risk for cerebral and cardiorenovascular disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Once daily after breakfast (generally within 30 minutes after eating)
febuxostat
Febuxostat will be taken once daily after breakfast (generally within 30 minutes after eating) but can be taken around the time of breakfast even if no food has been eaten. When the dose is to be increased, the principal or sub-investigator will carry out any required examinations and tests as needed. The starting dose of the investigational product (febuxostat) will be 10 mg/day. The dose will be increased to 20 mg/day at Week 4. The aim is to increase the dose to 40 mg/day at Week 8.
(No Intervention)
No febuxostat treatment

Primary Outcomes

Measure
Development of cerebral or cardiorenovascular events and all deaths
time frame: Enrollment through Month 36

Secondary Outcomes

Measure
Occurrence of cerebral or cardiorenovascular event by event
time frame: Enrollment through Month 36
Occurrence of cerebral or cardiorenovascular event by serum uric acid level
time frame: Enrollment through Month 36
Occurrence of cerebral or cardiorenovascular event by prior history of cerebral or cardiorenovascular disease
time frame: Enrollment through Month 36
Serum uric acid level
time frame: At screening, at enrollment, at 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or at withdrawal from the study)
Change in serum uric acid level
time frame: Enrollment through Week 4
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Week 8
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Week 12
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 6
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 12
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 18
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 24
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 30
Amount of change and percent change in serum uric acid level
time frame: Enrollment through Month 36 (or withdrawal from the study)
Percent Achieving serum uric acid level of 6.0mg/dL
time frame: Enrollment to completion of study or withdrawal
Estimated glomerular filtration rate (eGFR)
time frame: Enrollment, 4, 8, and 12 weeks and 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Amount of change and percent change in eGFR
time frame: Enrollment through Week 4
Amount of change and percent change in eGFR
time frame: Enrollment through Week 8
Amount of change and percent change in eGFR
time frame: Enrollment through Week 12
Amount of change and percent change in eGFR
time frame: Enrollment through Month 6
Amount of change and percent change in eGFR
time frame: Enrollment through Month 12
Amount of change and percent change in eGFR
time frame: Enrollment through Month 18
Amount of change and percent change in eGFR
time frame: Enrollment through Month 24
Amount of change and percent change in eGFR
time frame: Enrollment through Month 30
Amount of change and percent change in eGFR
time frame: Enrollment through Month 36 (or withdrawal from the study)
Urine microalbumin-creatinine ratio
time frame: Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Amount of change and percent change in urine microalbumin-creatinine ratio
time frame: Enrollment through Month 6
Amount of change and percent change in urine microalbumin-creatinine ratio
time frame: Enrollment through Month 12
Amount of change and percent change in urine microalbumin-creatinine ratio
time frame: Enrollment through Month 24
Amount of change and percent change in urine microalbumin-creatinine ratio
time frame: Enrollment through Month 36 (or withdrawal from the study)
Quantification of urinary protein
time frame: Enrollment, 6, 12, 24, and 36 months (or withdrawal from the study)
Amount of change and percent change in quantified urinary protein
time frame: Enrollment through Month 6
Amount of change and percent change in quantified urinary protein
time frame: Enrollment through Month 12
Amount of change and percent change in quantified urinary protein
time frame: Enrollment through Month 24
Amount of change and percent change in quantitative urinary protein
time frame: Enrollment through Month 36 (or withdrawal from the study)
Blood pressure (systolic/diastolic)
time frame: Enrollment, 6, 12, 18, 24, 30, and 36 months (or withdrawal from the study)
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 6
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 12
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 18
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 24
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 30
Amount of change and percent change in blood pressure (systolic/diastolic)
time frame: Enrollment through Month 36 (or withdrawal from the study)
Occurrence of adverse events
time frame: Enrollment through Month 36
Occurrence of cerebral or cardiorenovascular events in the febuxostat group during the study period by febuxostat dose
time frame: Enrollment through Month 36
Occurrence of cerebral or cardiorenovascular events in the non-febuxostat group during the study period by use of allopurinol
time frame: Enrollment through Month 36

Eligibility Criteria

Male or female participants at least 65 years old.

Inclusion Criteria: - (1) Patients 65 years of age or older at enrollment who are able to visit - (2) Patients with hyperuricemia, who have a serum uric acid level >7.0 mg/dL and <= 9.0 mg/dL (7.0 mg/dL < serum uric acid level <= 9.0 mg/dL) within 2 months prior to enrollment - (3) Patients at risk for any of the cerebral or cardiorenovascular diseases in i) through iv) below (i) Previous or current history of hypertension (ii) Previous or current history of type 2 diabetes mellitus (iii) Renal disorders (30 mL/min/1.73 m2 <= eGFR < 60 mL/min/1.73 m2 within 3 months prior to enrollment) (iv) Previous history of cerebral or cardiorenovascular disease for more than 3 months prior to enrollment (stroke [cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage], coronary artery disease, vascular disease, or cardiac failure) - (4) Patients who personally give written informed consent to participate in this study Exclusion Criteria: - (1) Patients with gouty tophus, or patients with subjective symptoms of gouty arthritis within 1 year prior to enrollment - (2) Patients with a previous history of hypersensitivity to febuxostat or allopurinol - (3) Patients with malignant tumors - (4) Patients with serious kidney disease, Acute kidney disease, nephrotic syndrome, dialysis patients, kidney transplant patients, eGFR < 30 mL/min/1.73 m2 , etc. - (5) Patients with a previous history of acute coronary syndrome or stroke within 3 months prior to enrollment (cerebral hemorrhage, cerebral infarction, or subarachnoid hemorrhage) - (6) Patients with a >= 50% increase in serum creatinine within 3 months prior to enrollment - (7) Patients with severe hypertension characterized by systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 110 mmHg within 3 months prior to enrollment - (8) Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 or more times the upper limit of normal within 3 months prior to enrollment - (9) Patients on any of the following medications at enrollment Mercaptopurine hydrate, azathioprine, vidarabine, or didanosine - (10) Patients who receive any of the following medications for the treatment of hyperuricemia within 1 month prior to enrollment Allopurinol, benzbromarone, probenecid, bucolome, topiroxostat, or febuxostat - (11) Patients who start, modify the dose of, or discontinue any of the following medications within 1 month prior to enrollment Losartan, irbesartan, fenofibrate, thiazide diuretics, or loop diuretics - (12) Patients on hormone replacement therapy with estrogen (estrogenic hormone products) - (13) Patients who have participated in other clinical research (including trials) within 6 months prior to enrollment (non-interventional observational research not excluded) - (14) Patients otherwise judged by the principal or sub-investigator to be unsuitable for the study

Additional Information

Official title A Multicenter, Randomized, Comparative Trial on the Effect of Febuxostat in Preventing Cerebral and Cardiorenovascular Events in Patients With Hyperuricemia
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Freed Study Group.