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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006616
Receipt No. R000007817
Scientific Title PRevention of End stage kidney disease by Darbepoetin Alfa In CKD patients with non-diabeTic kidney disease.
Date of disclosure of the study information 2011/10/27
Last modified on 2016/04/26

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Basic information
Public title PRevention of End stage kidney disease by Darbepoetin Alfa In CKD patients with non-diabeTic kidney disease.
Acronym PREDICT
Scientific Title PRevention of End stage kidney disease by Darbepoetin Alfa In CKD patients with non-diabeTic kidney disease.
Scientific Title:Acronym PREDICT
Region
Japan

Condition
Condition Chronic Kidney Dosease patients without diabetes
Classification by specialty
Nephrology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ask whether treating non-biabetic CKD patients with GFR 8-20mL/min/1.73m2 by darbepoetin Alfa targeting Hb between 11.0 and 13.0g/dL preserves renal function better than targeting Hb between 9.0 and11.0g/dL.
We also ask whether the higher Hb targeting 11 to 13g/dL will not cause higher adverse events regarding cardiovascular diseases compared with lower Hb targeting 9 to 11g/dL.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, and eGFR less than 50% of intial value.
Key secondary outcomes 1) Composite cardiovascular outcome of cardiovascular death, stroke, myocardial infarction, amputation above foot, admission by heart failure or angina.
2) Time from enrollment to initiation of dialysis
3) Time from enrollment to 50% reduction of eGFR from initial value
4) Time from enrollment to death bu any cause
5) Change of eGFR from enrollment
6) Change of proteinuria/Cr ratio.
7) Per protocol analysis of patients targeted Hb value maintained more than 50%.
8) Time from intiation to 50% reduction of eGFR from enrollment.
9) Event of stroke
10) Event of myoxardial infarction
11) Event of development of malignancy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
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 High Hb group
Targeting Hb is 12g/dL and keep maintaining Hb 11.og/dL and higher and less than 13.0g/dL.
If the patients do not have medical histry of myocardial infarction, stroke, plumonary embolism, unstable angina, peripheral artery disease, the targeting Hb willl be more than 12.0g/dL and less than 13.0g/dL.
Maximum dose of darbepoetin alfa is 240 microgram per 4 weeks.

Interventions/Control_2 Low Hb group
Targeting Hb is 10.0g/dL and try to maintain 9.0 and higher and less than 11.0g/dL. If the patients have Hb exceeded 10.0g/dL, dalbepoetin should be reduced or stopped.
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 1) CKD patients who have notchronically treated with dialysis
2) eGFR 8 and more and less than 20 mL/min/1.73m2 determined twice in last 12 weeks.
3) CKD patients with renal anemia at Hb less than 10g/dL within last 4 weeks
4) CKD patiens with TSAT 20% and higher or serum ferritin 100ng/mL and higher.
5) CKD patients treated with standard care
6) CKD patients provided written informed consent.
Key exclusion criteria 1) Diabetes (HbA1c 6.4% IFCC)
2) CKD patients treated with ESA other than epoetins.
3) CKD patients treated with epoetin 36000 IU or more.
4) Hypertension (180/10mmHg and higher)
5) Heart failure (NYHA III and IV)
6) malignancy, hematological disorder
7) malnuturition
8) Active and continuous gastrointestinal tract bleeding
9) ANCA associated glomerulonephritis, acute infection, active SLE
10) CKD patients who will be started dialysis or will receive tranplantation
11) Myocardial infarction within last 6 months
12) Stroke or plumonary embolism within last 12 months
13) Severe allergy
14) Pregnant woman or CKD patients who wish to be pregnant
15) Allergy against erythropoetin
16) CKD patients who is not appropriate to entry the clincal trial
Target sample size 440

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Akizawa
Organization Showa University School of Medicine
Division name Nephrology
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email akizawa@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name ENYU IMAI
Organization Nakayamadera Imai Clinic
Division name Nephrology
Zip code
Address 2-2-6, Mukoyama, Takataduka
TEL 0797-86-2600
Homepage URL
Email ADS12069@nifty.com

Sponsor
Institute PREDICT steering committee
Institute
Department

Funding Source
Organization Translational Informatics Research Center
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 公立陶生病院(愛知県)、金沢大学附属病院(石川県)、江南厚生病院(愛知県)、安城更生病院(愛知県)、神戸市立医療センター中央市民病院(兵庫県)、名古屋第二赤十字病院(愛知県)、中部ろうさい病院(愛知県)、北海道大学病院(北海道)、順天堂大学医学部附属順天堂医院(東京都)、東北大学(宮城県)、名古屋大学医学部附属病院(愛知県)、筑波大学(茨城県)、九州大学(福岡県)、豊田厚生病院(愛知県)、埼玉医科大学(埼玉県)、自治医科大学(栃木県)、大阪大学医学部附属病院(大阪府)、東京女子医科大学(東京都)、東京医科大学(東京都)、名古屋第一赤十字病院(愛知県)、広島大学病院(広島県)、藤田保健衛生大学医学部(愛知県)、春日井市民病院(愛知県)、新潟大学大学院医歯学総合研究科(新潟県)、北野病院(大阪府)、福島県立医科大学(福島県)、日本大学医学部附属板橋病院(東京都)、帝京大学医学部附属病院(東京都)、久留米大学病院(福岡県)、金沢医科大学病院(石川県)、神戸大学医学部附属病院(兵庫県)、横浜市立大学附属市民総合医療センター(神奈川県)、市立四日市病院(三重県)、昭和大学横浜市北部病院(神奈川県)、仙台社会保険病院(宮城県)、社会保険中京病院(愛知県)、昭和大学藤が丘病院(神奈川県)、東京大学医学部附属病院(東京都)、岡山大学大学院医歯薬学総合研究科(岡山県)、武蔵野赤十字病院(東京都)、海南病院(愛知県)、聖路加国際病院(東京都)、昭和大学病院(東京都)、大垣市民病院(岐阜県)、兵庫医科大学病院(兵庫県)、大阪府立急性期・総合医療センター(大阪府)、横須賀共済病院(神奈川県)、香川大学医学部附属病院(香川県)、札幌医科大学附属病院(北海道)、福岡赤十字病院(福岡県)、京都府立医科大学(京都府)、近江八幡市立総合医療センター(滋賀県)、京都大学大学院医学研究科(京都府)、津島市民病院(愛知県)、板橋中央総合病院(東京都)、小牧市民病院(愛知県)、小倉記念病院(福岡県)、宮崎大学医学部附属病院(宮崎県)、製鉄記念八幡病院(福岡県)、聖マリア病院(福岡県)、熊本赤十字病院(熊本県)、鹿児島大学病院(鹿児島県)、小千谷総合病院(新潟県)、半田市立半田病院(愛知県)、大分赤十字病院(大分県)、浜の町病院(福岡県)、飯塚病院(福岡県)、宗像医師会病院(福岡県)、熊本中央病院(熊本県)、豊見城中央病院(沖縄県)、済生会熊本病院(熊本県)、琉球大学 医学部附属病院(沖縄県)、あけぼのクリニック(熊本県)、三井記念病院(東京都)、東京逓信病院(東京都)、新潟臨港病院(新潟県)、上越総合病院(新潟県)、長岡赤十字病院(新潟県)、産業医科大学病院(福岡県)、新潟県立新発田病院(新潟県)、日本赤十字社医療センター(東京都)、新潟市民病院(新潟県)、佐渡総合病院(新潟県)、下越病院(新潟県)、九州医療センター(福岡県)、名古屋共立病院(愛知県)、名古屋医療センター(愛知県)、池田バスキュラ―アクセス 透析・内科クリニック(福岡県)、増子記念病院(愛知県)、信楽園病院(新潟県)、立川綜合病院(新潟県)、長岡中央綜合病院(新潟県)、豊橋市民病院(愛知県)、宮崎県立宮崎病院(宮崎県)、大野記念病院(大阪府)、木戸病院(新潟県)、名古屋記念病院(愛知県)、トヨタ記念病院(愛知県)、新潟医療センター(新潟県)、一宮市立市民病院(愛知県)、池田病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 27 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
2011 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 03 Month 01 Day
Date trial data considered complete
2017 Year 06 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 10 Month 26 Day
Last modified on
2016 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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