UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008505 |
|---|---|
| Receipt number | R000009994 |
| Scientific Title | A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD). |
| Date of disclosure of the study information | 2012/07/23 |
| Last modified on | 2020/07/31 22:16:18 |
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Basic information
Public title
A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).
Acronym
A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).
Scientific Title
A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).
Scientific Title:Acronym
A prospective comparison of epoetin beta pegol and darbepoetin alpha in the variability of blood pressure in pre-dialysis chronic kidney disease (CKD).
Region
| Japan |
Condition
Condition
Chronic kidney disease
anemia
Classification by specialty
| Medicine in general | Cardiology | Hematology and clinical oncology |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares effects of epoetin beta pegol and darbepoetin alpha on blood pressure variability, in pre-dialysis chronic kidney disease patients who have not been treated with recombinant human erythropoietin (rHuEPO) yet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Blood pressure variability(clinical BP, pulse rate, central blood pressure, PWV, pulse pressure, CAVI, ABPM)
Key secondary outcomes
1.Cardio vascular events
2.Hemoglobin
3.Estimated GFR
4.Serum creatinine
5.Proteinuria
6.Dialysis initiation
7.Renal transplantation
8.mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epoetin beta pegol groups: Patients are initially given 25-250 micrograms of epoetin beta pegol once a month for 48 weeks.
Interventions/Control_2
darbepoetin alpha groups: Patients are initially given 60-180 micrograms of darbepoetin alpha once a month for 48 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Pre-dialysis chronic kidney disease
2.20 years and over
3.Above 40 kg, below 80 kg
4.estimated GFR<60 ml/min/1.73m2 (within 12 weeks)
5.TSAT=>20% (within 4 weeks)
6.Hemoglobin level<=11.0g/dL (within 8 weeks)
7.Patients who have not recieved rHuEPO within 12 weeks
Key exclusion criteria
1.Severe hypertension(diastolic blood pressure is over 100 mmHg within 12 weeks)
2.Congestive heart failure(NYHA class3, 4)
3.Pregnant women and/or women who are suspect of pregnancy
4.History or complication of cardiac infarction, pulmonary embolism or symptomatic cerebral infarction
5.History of hypersensitivity to epoetin beta pegol and/or darbepoetin alpha
6.Patients with malignancy, severe infection, systemic blood disease(MDS, etc.), hemolytic anemia or hemorrhagic disease
7.Administration of anabolic steroids, testosterone enanthate or mepitiostane within 12 weeks
8.Erythrocyte transfusion within 16 weeks
9.Patients who will plan to undergo a severe bleeding surgery
10.Patients judged as inappropriate for the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
Homepage URL
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
045-787-2800
onodera@yokohama-cu.ac.jp
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 | 23 | Day |
Related information
URL releasing protocol
https://www.karger.com/Article/FullText/507396
Publication of results
Published
Result
URL related to results and publications
https://www.karger.com/Article/FullText/507396
Number of participants that the trial has enrolled
36
Results
Office/ambulatory BP, renal function, and
other parameters were not significantly different between groups. Although office/ambulatory BP profiles had not worsened after 24 weeks of ESA treatment, more than half of the patients required an increase in the antihypertensive agent dose.
Results date posted
| 2020 | Year | 07 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (years);CERA vs DA: 72.1+-9.4 vs 75.9+-8.0.
eGFR (mL/min/1.73m^2);CERA vs DA: 20.3+-6.3 vs 20.7+-14.0.
Participant flow
Thirty-six eligible patients with renal anemia were enrolled and were randomly assigned to the CERA group (n = 18) or the DA group (n = 18) .
Adverse events
No.
Outcome measures
office BP and ambulatory BP profiles.
renal function, Hb levels, the number of patients who required dialysis, and the number of CVD events and other adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009994
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