The effect of febuxostat to prevent a further reduction in renal function of patients with hyperuricemia who have never had gout and are complicated by chronic kidney disease stage 3: study protocol for a multicenter randomized controlled study

Hosoya, Tatsuo; Kimura, Kenjiro; Itoh, Sadayoshi; Inaba, Masaaki; Uchida, Shunya; Tomino, Yasuhiko; Makino, Hirofumi; Matsuo, Seiichi; Yamamoto, Tetsuya; Ohno, Iwao; Shibagaki, Yugo; Iimuro, Satoshi; Imai, Naohiko; Kuwabara, Masanari; Hayakawa, Hiroshi

doi:10.1186/1745-6215-15-26

Trials

Table 2 Schedule for observation, testing, and assessment

From: The effect of febuxostat to prevent a further reduction in renal function of patients with hyperuricemia who have never had gout and are complicated by chronic kidney disease stage 3: study protocol for a multicenter randomized controlled study

		Timing
Items		Eligibility confirmation	Enrollment and assignment	Baseline	Treatment phase
Visit^a		1		2	3	4	5	6	7	8	9	10	11	12	13
Week after treatment onset^a		-4		0	4	8	12	24	36	48	60	72	84	96	108
Acquisition of informed consent		X
Pregnancy test^b, gender, and date of birth		X
Smoking history, anamnesis, and complications				X
Status of study drug intake					X	X	X	X	X	X	X	X	X	X	X
Status of concurrent therapy^c		X		X	X	X	X	X	X	X	X	X	X	X	X
Commencement of dialysis					X	X	X	X	X	X	X	X	X	X	X
Development of gouty arthritis					X	X	X	X	X	X	X	X	X	X	X
Development of adverse events					X	X	X	X	X	X	X	X	X	X	X
Height (second visit only), body weight, and BMI				X						X					X
Blood pressure (systolic, diastolic) and pulse rate		X^d		X	X	X	X	X	X	X	X	X	X	X	X
12-lead electrocardiogram				X^e											X^f
Hematology blood chemistry^g, and urinalysis^h		X^d		X	X	X	X	X	X	X	X	X	X	X	X
Blood	Serum urateⁱ and creatinine concentrations	X^d		√	√	√	√	√	√	√	√	√	√	√	√
	T-C, HDL-C, and TG			√ at fasting
	HbA1c	X^j		√						√					√
	Markers^k			√						√					√
Urine	Urinary creatinine, albumin, and urateⁱ concentrations			√						√					√
	Markers^k			√						√					√
Blood sampling volume for measurement at the central laboratory (mL)				16	10	10	10	10	10	16	10	10	10	10	16

X: Measurement at the institution’s laboratory; √: Measurement at the central laboratory.
^aCorresponds to the time of completion, discontinuation, or withdrawal.
^bFor the premenopausal female patient only.
^cAntihypertensives, antihyperlipidemics, antidiabetics, non-steroidal anti-inflammatory drugs, adrenocortical steroids, theophylline, colchicine, and part of contraindicated and restricted concurrent therapies.
^dBlood pressure, serum urate concentration, serum creatinine concentration, alanine aminotransferase, and aspartate aminotransferase are required to confirm eligibility. Urine protein (qualitative) is required to adjust allocation.
^eData obtained within 6 months before consent acquisition should be acceptable, unless cardiovascular or other events have developed. Data within 3 months before and after study completion should be acceptable.
^fRed blood cell count, white blood cell count, platelet count, hemoglobin, and hematocrit.
^gAlanine aminotransferase, aspartate aminotransferase, γ-glutamyl transpeptidase, blood urea nitrogen, creatine kinase, and blood electrolytes (Na, K, and Cl).
^hUrine protein, urine glucose, occult blood reaction, urine pH, and N-acetylglucosaminidase.
ⁱSerum urate concentration and urinary urate concentration should be measured at the central laboratory only during the study period. Measurement results obtained at the central laboratory should be transmitted to the institutions, but serum urate concentration and urinary urate concentration should not.
^jShould be measured for the patient who is suspected of having diabetes.
^kSerum cystatin C, urinary 8-hydroxy-2’-deoxyguanosine, urinary liver-type fatty acid-binding protein, serum C-reactive protein, and serum N-terminal pro-brain-type natriuretic peptide.
BMI, body mass index; T-C, total cholesterol; HDLC, high-density lipoprotein cholesterol; TG, triglyceride.

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ISSN: 1745-6215

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