UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008568 |
|---|---|
| Receipt number | 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 15:25:37 |
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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
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
| 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
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
kawashimaizm@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010042
