UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008505
Receipt No. 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 (Ver. 12)

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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
Email 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
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009994