UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010138 |
|---|---|
| Receipt number | R000011871 |
| Scientific Title | Prognostic evaluation for renal anemia patients on hemodialysis based upon hemoglobin levels during treatment with Epoetin Beta Pegol: multicenter prospective study |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2022/02/22 10:51:14 |
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Basic information
Public title
Prognostic evaluation for renal anemia patients on hemodialysis based upon hemoglobin levels during treatment with Epoetin Beta Pegol: multicenter prospective study
Acronym
PARAMOUNT-HD Study
Scientific Title
Prognostic evaluation for renal anemia patients on hemodialysis based upon hemoglobin levels during treatment with Epoetin Beta Pegol: multicenter prospective study
Scientific Title:Acronym
PARAMOUNT-HD Study
Region
| Japan |
Condition
Condition
Renal anemia on hemodialysis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to renal anemia patients on hemodialysis who were poor responder to ESA.
Difference in prognosis according to whether or not the subject shows a poor response to ESAs will also be examined using the data from the noninterventional observational part of the study as the control. A search for factors affecting poor response to ESAs will also be conducted using the data from the prospective study as a whole.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cardiovascular prognosis(randomized study part)
Time to cardiovascular events such as cardiac death (death with heart failure, lethal myocardial infarction, sudden cardiac death), heart failure requiring hospitalization, and acute coronary syndrome (nonfatal myocardial infarction, unstable angina) requiring hospitalization.
(observational study part)
Cardiovascular events
a. Relationship with ERI
b. Relationship with iron
Key secondary outcomes
(randomized study part)
(1) Cardiovascular events
(2) Death
(3) Relationship between iron index and prognosis
(4) Quality of life
(5) Safety
(observational study part)
(1)Cerebrovascular events, composite events and total deaths
a. Relationship with ERI
b. Relationship with iron indices
(2)Relationship between hemoglobin and cardiovascular events and cerebrovascular events
(3)Safety
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(randomized study part)
Active group:
Patients take epoetin beta pegol with the target hemoglobin level of 11 g/dL or more.
Maintenance group:
Patients take epoetin beta pegol to maintain their hemoglobin levels at 9-10 g/dL.
Interventions/Control_2
(randomized study part)
Maintenance group:
Patients take epoetin beta pegol to maintain their hemoglobin levels at 9-10 g/dL.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(randomized study part)
1. Between 20 and 85 years of age (inclusive) at the time of giving informed consent
2. Receiving drug therapy with ESA other
3.More than one year after dialysis induction
4. A poor ESA responder,defined as no improvement in anemia after six months'treatment with an ESA.
5. Is not iron deficient.
6. Has personally consented in writing to participate in the randomized part of the study.
(observational study part)
1. 20 years of age or older at the time of giving informed consent
2. Receiving treatment for renal anemia with an ESA other than epoetin beta pegol and is scheduled to be switched to epoetin beta pegol.
3. Has been on hemodialysis for at least one year.
4. Has personally consented in writing to participate in the study.
Key exclusion criteria
(randomized study part)
(1) Anemia for other reasons than the renal anemia:Complication of apparent hemorrhagic lesion, hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or apparent chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease)
(2) Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa
(3) Complication of malignant tumor
(4) Pregnancy, nursing or planning to become pregnant during the study (women only)
(5) Judged as ineligible to the randomized study in the opinion of the investigator
(observational study part)
1.Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa
2.Pregnancy, nursing or planning to become pregnant during the study (women only)
3.Judged as ineligible to the randomized study in the opinion of the investigator
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | Kosaku |
| Middle name | |
| Last name | Nitta |
Organization
Tokyo Women's Medical University
Division name
Department of Medicine
Zip code
162-8666
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
prj-paramount-hd@eps.co.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Omote |
Organization
EP CRSU Co., Ltd.
Division name
Clinical Research Promotion Dept.
Zip code
162-0814
Address
6-29 Shinogawa-machi, Shinjyuku-ku, Tokyo, 162-0814
TEL
03-6759-9904
Homepage URL
http://paramount-hd.org/
prj-paramount-hd@eps.co.jp
Sponsor or person
Institute
EP CRSU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS IRB
Address
5-20-9-401, Mita Minato-ku, Tokyo Japan, 108-0073
Tel
03-6416-1868
Npo-mins@j-irb.com
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
医療法人社団洛和会 洛和会音羽記念病院（京都府）、医療法人尚腎会 高知高須病院（高知県）、町立中標津病院（北海道）、医療法人社団養生館 苫小牧日翔病院（北海道）、医療法人社団石川記念会 新宿石川クリニック（東京都）、特定医療法人明仁会 明舞中央病院（兵庫県）、公益財団法人ときわ会 常磐病院（福島県）、 医療法人待望主会 安立医院（沖縄県）、医療法人財団博仁会 キナシ大林病院（香川県）、医療法人社団喜多町診療所（新潟県）、医療法人仁栄会 島津クリニック（高知県）、社会医療法人社団順江会 東京綾瀬腎クリニック（東京都）、医療法人社団英山会 平山泌尿器科医院（熊本県）、独立行政法人 地域医療機能推進機構 横浜中央病院（神奈川県）、医療法人 いぶきクリニック 分院（大阪府）、ＪＡ徳島厚生連 吉野川医療センター（徳島県）、医療法人社団日高会 平成日高クリニック（群馬県）、社会医療法人川島会 川島病院（徳島県）、こひつじ会グループ 医療法人社団小羊会 千葉横戸クリニック（千葉県）、社会医療法人信愛会 畷生会脳神経外科病院（大阪府）、こひつじ会グループ 医療法人社団小羊会 長沼クリニック（千葉県）、医療法人 中央内科クリニック（広島県）、医療法人社団玄成会 達内科（宮城県）、医療法人以和貴会 西崎病院（沖縄県）、岩見沢市立総合病院（北海道）、社会医療法人北楡会 札幌北楡病院（北海道）、医療法人青仁会 池田病院（鹿児島県）、医療法人社団明洋会 柴垣医院 戸越（東京都）、医療法人財団倉田会 えいじんクリニック（神奈川県）、医療法人知邑舎 メディカルサテライト岩倉（愛知県）、医療法人社団一陽会 一陽会クリニック（広島県）、医療法人明和会 たまき青空病院（徳島県）、医療法人社団恵仁会 三島外科胃腸クリニック（愛媛県）、医療法人親和会 天神クリニック（福岡県）、医療法人進和会 西２条腎泌尿器科病院（北海道）、ＪＡ北海道厚生連 旭川厚生病院（北海道）、日本赤十字社 旭川赤十字病院（北海道）、公益財団法人湯浅報恩会 寿泉堂クリニック（福島県）、医療法人翠悠会 翠悠会診療所（奈良県）、福島県厚生農業協同組合連合会 白河厚生総合病院（福島県）、医療法人社団 清和会 笠岡第一病院（岡山県）、医療法人社団 天成会 天野医院（静岡県）、一般財団法人 脳神経疾患研究所附属 総合南東北病院（福島県）、医療法人社団豊済会 下落合クリニック（東京都）、公益財団法人 東京都保健医療公社 大久保病院（東京都）、医療法人社団 菅沼会 腎内科クリニック世田谷（東京都）、社会医療法人愛仁会 千船腎臓透析クリニック（大阪府）、医療法人青松会 のへじクリニック（青森県）、医療法人社団秀佑会 東海病院（東京都）、前田記念腎研究所 茂原クリニック（千葉県）、国家公務員共済組合連合会 横浜栄共済病院（神奈川県）他376施設
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
PARAMOUNT-HD Study(randomized study part+observational study part) is a multicenter prospective study of 5,000 renal anemia patients on hemodialysis. The PARAMOUNT-HD study is planned as a comprehensive design to perform simultaneously progressing randomized controlled study for 530 patients who were poor EPA responders and an observational study for 4,470 patients.
Primary objective of the PARAMOUNT-HD study is to evaluate the relationship between prognosis and ESA response following epoetin beta pegol therapy in renal anemia patients on hemodialysis.
Management information
Registered date
| 2013 | Year | 02 | Month | 28 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011871
