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Recruitment status Completed
Unique ID issued by UMIN UMIN000008568
Receipt No. R000010042
Scientific Title Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
Date of disclosure of the study information 2012/07/31
Last modified on 2018/10/17

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Basic information
Public title Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
Acronym MIRACLE-CKD
Scientific Title Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
Scientific Title:Acronym 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
1st name
Middle name
Last name JOJI MOCHIZUKI
Organization CHUGAI PHARMACEUTICAL CO., LTD.
Division name PHARMACOVIGILANCE DEPT.
Zip code
Address 2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
TEL 03-3273-0769
Email mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name IZUMI KAWASHIMA
Organization CHUGAI PHARMACEUTICAL CO., LTD.
Division name PHARMACOVIGILANCE DEPT.
Zip code
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://rd.springer.com/article/10.1007/s10157-018-1649-0
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000010042


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