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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023648
Receipt No. R000026360
Scientific Title Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M
Date of disclosure of the study information 2016/08/17
Last modified on 2019/02/18

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Basic information
Public title Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M
Acronym EPISODE
Scientific Title Evaluation for new Phosphate Iron-based binder , Sucroferric Oxyhydroxide in Dialysis patient for E.B.M
Scientific Title:Acronym EPISODE
Region
Japan

Condition
Condition hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect on the coronary artery calcification at sucroferric oxyhydroxide and lanthanum carbonate in chronic dialysis patients, the randomized trials using both drugs and serum P concentration values 2X2 factorial design at a therapeutic target consider.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the rate of change of coronary artery calcification index at the start and after 12 months
Key secondary outcomes 1. changes in CACS,
2. changes in serum phosphate and calcium levels,changes in calcium phosphate product, and the ratio of patients who reached the target serum phosphate level,
3. changes in the level of intact parathyroid hormone (PTH), intact fibroblast growth factor (FGF)-23, and c-terminalFGF23,
4. effects on the renal anemia, assessed by transferrin saturation(TSAT), hemoglobin, and the changes in the dose of iron and EPO administration,
5. relationship between serum phosphate level and CACS,
6. average doses of phosphate binder required to achieve the target serum phosphate level,
7. safety issue (adverse drug reactions).

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Sucroferric oxyhydroxide 750 to 3,000mg/day
12months medication
Serum phosphorus value treatment goal 6.0mg/dL less than 5.0mg/dL or more
Interventions/Control_2 Lanthanum carbonate 750 to 2,250mg/day
12months medication
Serum phosphorus value treatment goal 6.0mg/dL less than 5.0mg/dL or more
Interventions/Control_3 Sucroferric oxyhydroxide 750 to 3,000mg/day
12 months medication
Serum phosphorus value treatment goal 4.5mg/dL less than 3.5mg/dL or more
Interventions/Control_4 Lanthanum carbonate 750 to 2,250mg/day
12 months medication
Serum phosphorus value treatment goal 4.5mg/dL less than 3.5mg/dL or more
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with hyperphosphatemia in chronic maintenance dialysis.
2.Patients of the following serum P concentration before dialysis in observation period.
In the case of patients with medication, the phosphorus adsorbent in the observation period is serum P concentration of 5.0mg/dL or more.
In the case of patients with not medication, the phosphorus adsorbent in the observation period is serum P concentration of 6.1mg/dL or more.
3.Patients have elapsed dialysis after more than three months
4.Patients have received three times a week or more of stable hemodialysis (HD or HDF), and patients will continue to similar blood dialysis until the end of the treatment period start.
5.CACS of a patient is more than 30 that is measured during the observation period.
6.Patients are older 20-year-old or less than 80-year-old.
7.Outpatients
8.Gender does not matter.
9.Patients were obtained informed consent.
Key exclusion criteria 1.Before dialysis, serum intact-PTH concentration of previously registered one month is exceeds 800 pg/mL or over 500pg/mL, it is determined that the uncontrolled.
2.Patients have hemochromatosis or patients have a history of other iron storage disorders, or serum ferritin concentration before dialysis of the observation period at the start is over 300ng/mL or TSAT is more than 50%.
3.Patients have severe liver dysfunction (C chronic hepatitis, etc.).
4.Patients have severe coronary artery disease
5.Patients are merged malignant tumor.
6.Patients are paroxysmal nocturnal hemoglobinuria.
7.Patients have hypersensitivity iron-containing formulations or lanthanum-containing formulations.
8.Patients received PTX.
9.Patients suspect of being pregnant or pregnant.
10.Research investigators or research sharing investigators have determined to the patient is inappropriate as a subject of the study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Isaka
Organization Osaka University Graduate School of Medicine
Division name Department of Nephrology
Zip code
Address 2-2, Yamada-oka, Suita, Osaka,565-0871,Japan
TEL 06-6879-3857
Email isaka@kid.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihide Oshima
Organization The Japan Clinical Research Forum
Division name Secretariat
Zip code
Address 1-8-29 NIshimiyahara, Yodogawa-ku, Osaka-City,532-0004,Japan
TEL 06-6398-5192
Homepage URL
Email oshima@jarf.or.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Nephrology
Institute
Department

Funding Source
Organization Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 医療法人健栄会 三康病院附属診療所 (大阪府)
医療法人健栄会 三康クリニック (大阪府)
三康病院グループ 三康診療所 (大阪府)
医療法人蒼龍会 井上病院 (大阪府)
医療法人 すみれ会 今井クリニック (大阪府)
医療法人 裕生会 裕生会クリニック (大阪府)
医療法人 淳康会 堺近森病院 (大阪府)
医療法人 西診療所 (大阪府)
医療法人社団 星晶会 愛正透析クリニック (大阪府)
医療法人育祥会 須澤クリニック (大阪府)  
社会医療法人純幸会 関西メディカル病院 (大阪府)                  
社会医療法人純幸会 関西メディカル病院附属 豊中渡辺クリニック (大阪府)
特定医療法人紀陽会 北花田クリニック (大阪府)
特定医療法人紀陽会 長居クリニック (大阪府)
社会医療法人 彩樹 豊中けいじん会クリニック (大阪府)
社会医療法人 彩樹 寝屋川けいじん会クリニック (大阪府)
社会医療法人 彩樹 門真けいじん会クリニック (大阪府)
社会医療法人 彩樹 守口けいじん会クリニック (大阪府)
医療法人徳靖会 小尾クリニック (大阪府)
医療法人徳靖会 昭和町小尾クリニック(旧 医療法人和光会 橋中診療所) (大阪府)
特定医療法人五仁会 元町HDクリニック (兵庫県)
医療法人 谷口クリニック(旧 谷口クリニック) (大阪府)
医療法人医誠会 城東医誠会クリニック (大阪府)
医療法人好輝会 梶本クリニック (大阪府)
西脇市立西脇病院 (兵庫県)
医療法人 いぶきクリニック (大阪府)
医療法人桜希会 東朋八尾病院 (大阪府)
坂口クリニック (大阪府)
特定医療法人 光寿会 光寿会クリニック (兵庫県)
社会医療法人 愛仁会 千船腎臓・透析クリニック (大阪府)
社会医療法人 愛仁会 明石医療センター (兵庫県)
医療法人医誠会 大阪梅田医誠会透析クリニック
(旧 医療法人医誠会 桜橋医誠会クリニック) (大阪府)
医療法人良秀会 高石藤井病院 (大阪府)

【MDCT実施施設】
医療法人満領会画像診断クリニック(有田医院) (大阪府)
内田クリニック(大阪府)
社会医療法人 蒼生会 蒼生病院 (大阪府)
社会医療法人 裕生会 みどりヶ丘病院 (大阪府)
一般財団法人 住友病院 (大阪府)
特定医療法人 渡辺医学会 桜橋渡辺病院 (大阪府)
医療法人 川崎病院 (兵庫県)
兵庫医科大学病院 PETセンター(兵庫県)
社会医療法人 彩樹 守口敬仁会病院 (大阪府)
医療法人愛心会 東宝塚さとう病院 (大阪府)
医療法人彩樹 豊中緑ヶ丘病院 (大阪府)
社会医療法人純幸会 関西メディカル病院 (大阪府) 
医療法人錦秀会 阪和記念病院(大阪府)
特定医療法人紀陽会 田仲北野田病院 (大阪府)
医療法人蒼龍会 井上病院 (大阪府)
医療法人 谷口クリニック(旧 谷口クリニック) (大阪府)
社会医療法人 愛仁会 千船病院(兵庫県)
社会医療法人 愛仁会 明石医療センター (兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 17 Day

Related information
URL releasing protocol https://link.springer.com/article/10.1007/s10157-018-1547-5?wt_mc=Internal.Event.1.SEM.ArticleAuthor
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
2016 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 Day
Last follow-up date
2019 Year 04 Month 30 Day
Date of closure to data entry
2019 Year 05 Month 15 Day
Date trial data considered complete
2019 Year 05 Month 31 Day
Date analysis concluded
2019 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 17 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026360

Research Plan
Registered date File name
2018/03/13 20180116_ピートル実施計画書_ver.3.1版.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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