UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
Title of the study (Brief title)	MIRACLE-CKD
Region	Japan

Condition
Condition	Renal anemia associated with chronic kidney disease(CKD) not on dialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main objective of this study is to investigate the relation between maintenance hemoglobin levels and renal survival during MIRCERA administration to treat renal anemia in CKD patients not on dialysis.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Renal survival defined the periods until the earliest days occurred one of the three composite events; 1)renal replacement therapy 2)doubling of serum creatinine 3)eGFR less than 6.0mL/min/1.73m2
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CKD patients not on dialysis associated with renal anemia, and 1)MIRCERA-naïve patients with the hemoglobin level less than 11g/dL 2)patients estimated not to introduce dialysis for at least six months after starting MIRCERA administration
Key exclusion criteria	1)patients with anemia by other than renal anemia, such as by overt hemorrhage, by hematological disorders (leukemia, malignant lymphoma, myelodysplastic syndrome, or aplastic anemia, and others), and patients undergoing myelosuppressive treatment (chemotherapy or radiation therapy) 2)patients within one year after kidney transplantation 3)patients with eGFR of less than 6mL/min/1.73m2
Target sample size	5000

Research contact person
Name of lead principal investigator	JOJI MOCHIZUKI
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Division name	PHARMACOVIGILANCE DEPT.
Address	2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
TEL	03-3273-0769
Email	mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person	IZUMI KAWASHIMA
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Division name	PHARMACOVIGILANCE DEPT.
Address	2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
TEL	03-3273-0769
Homepage URL
Email	kawashimaizm@chugai-pharm.co.jp

Sponsor
Institute	CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department

Funding Source
Organization	CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 13 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 09 Month 30 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://rd.springer.com/article/10.1007/s10157-018-1649-0
Results	In a multicenter prospective observational study, Japanese NDCKD patients with an estimated glomerular filtration rate (eGFR) of >=6 mL/min/1.73 m2 and renal anemia (Hb <11 g/dL) treated with epoetin beta pegol (C.E.R.A.) for the first time were divided into 2 groups by Hb level (<11 g/dL or >=11 g/dL) in Week 12 of C.E.R.A. treatment (Week 12 Hb). Renal outcome was defined as time until first occurrence of one of the following: progression to renal replacement therapy, serum creatinine doubling, or eGFR falling below 6 mL/min/1.73 m2. The effect of Week 12 Hb on the onset of renal events was assessed by Kaplan-Meier and multivariate Cox regression analyses. In the landmark analysis included 2851 patients, Kaplan-Meier renal survival rate was 37.57% in the <11 g/dL group and was significantly higher (51.47%) in the >=11 g/dL group (P<0.0001). Multivariate Cox regression analysis revealed significantly higher risk of renal events in the <11 g/dL group than in the >=11 g/dL group (hazard ratio: 1.26; 95% confidence interval: 1.05-1.51; P=0.0103). The results suggest that Week 12 Hb levels >=11 g/dL achieved with C.E.R.A. treatment were associated with better renal outcomes than Hb levels <11 g/dL.
Other related information	The relation between maintenance hemoglobin levels and renal survival during MIRCERA administration will be analyzed as follows; 1)renal survival will be estimated bu using Kaplan-Meier method. 2)adjusted hazard ratio will be estimated by stratification of hemoglobin levels at three month after starting MIRCEA administaration(Landdmark analysis). 3)adjusted hazard ratio will be estimated by stratification of periods over 11 g/dL of hemoglobin level during one year after starting MIRCEA administaration. 4)hazard ratio will be estimated by using several suitable analytical methods including an inverse probability weighted (IPW) Cox model. 5)the relation between maintenance hemoglobin levels and change rate of eGFR will also be evaluated.

Management information
Registered date	2012 Year 07 Month 30 Day
Last modified on	2018 Year 10 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010042