UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040364 |
|---|---|
| Receipt number | R000046057 |
| Scientific Title | Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2024/03/29 15:01:18 |
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Basic information
Public title
Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients
Acronym
Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients
Scientific Title
Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients
Scientific Title:Acronym
Randomized controlled trial for the effect of HIF-PH inhibitor and epoetin beta pegol in renal anemia treatment of the peritoneal dialysis (PD) patients
Region
| Japan |
Condition
Condition
Peritoneal dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of changing to a HIF-PH inhibitor in patients using epoetin beta pegol on peritoneal dialysis patients.Primary endpoint includes Hb, and secondary endpoint includes Iron metabolism including hepcidin and peritoneal equilibration.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Transition of Hb, evaluated 12 weeks after assignment
Key secondary outcomes
Iron metabolism including hepcidin., evaluated 12 weeks after assignment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change of therapy from epoetin beta-pegol to HIF-PH inhibitor, followed by 12 weeks of treatment
Interventions/Control_2
Continue treatment with epoetin beta-pegol for 12 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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Peritoneal dialysis outpatients.
2) Patients from whom written informed consent was obtained.
Key exclusion criteria
Patients judged by the investigator to be unsuitable as subjects
1 Patients on concomitant hemodialysis (HD)or scheduled for HD during the institution.
2 Patients who developed peritonitis or catheter problems (e.g., tunnel infection) in the 4 weeks or more prior to the pre-examination and were considered to be interfering with the continuation of PD.
3 Patients with retinal neovascular lesions requiring treatment (e.g., proliferative diabetic retinopathy,exudative age-related macular degeneration,retinal vein occlusion)or macular edema requiring treatment.
4 Patients with inflammatory autoimmune diseases(systemic lupus erythematosus, rheumatoid arthritis,Sjogren's syndrome, celiac disease, etc.) that are thought to affect erythrocyte production.
5 Patients with a history of gastrointestinal resection(excluding gastric polypectomy and colorectal polypectomy)that may affect the absorption of drugs in the gastrointestinal tract or complicated by gastroparesis.
6 Patients with uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg in 1/3 of the measurements within 12 weeks prior to the pretest).
7 Patients with congestive heart failure (NYHA class 3 or higher)
8 Patients hospitalized for treatment of stroke, myocardial infarction or pulmonary infarction in the 12 weeks or more prior to the pre-examination
9 patients with positive hepatitis B virus surface HBs (antigens), hepatitis C virus (HCV)antibodies or human immunodeficiency virus (HIV) at the time of pretest.
10 Patients with anemia other than renal anemia (hemolytic anemia, pancytopenia, hemorrhagic anemia, etc.).
11 Patients scheduled for kidney transplantation during the study period.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | naoki |
| Middle name | |
| Last name | washida |
Organization
Department of Medicine, International University of Health and Welfare
Division name
nephrology
Zip code
2868686
Address
4-3, Ko-dunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
taka12402007@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Kasai |
Organization
Department of Medicine, International University of Health and Welfare
Division name
nephrology
Zip code
2868686
Address
4-3, Ko-dunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
Homepage URL
taka12402007@yahoo.co.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3, Ko-dunomori, Narita City, Chiba Prefecture
Tel
0476-20-7701
taka12402007@yahoo.co.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
| 2020 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046057
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