UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000023648
Receipt number	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 10:20:48

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

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

hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

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

Concealment

Central registration

Intervention

No. of arms

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 or person

Institute

Osaka University Graduate School of Medicine
Department of Nephrology

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026360