UMIN-CTR Clinical Trial

Public title

The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis

Acronym

Phosphor study

Scientific Title

The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis

Scientific Title:Acronym

Phosphor study

Region

Japan

Condition

hyperphosphatemia
chronic kidney disease (CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate impact of ferric citrate treatment on renal function in CKD patients with hyperphosphatemia or higher normal range of serum phosphorus

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

change from baseline in eGFR after 6, 12, 18, 24 months of follow-up

Key secondary outcomes

the time from randomization to the event of 30% decline in eGFR and the amount of change in serum phosphate, FGF23, intact PTH, calciprotein particles, ferritin, hemoglobin levels and the urinary phosphate levels

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

YES

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of ferric citrate for two years (daily dosage: 500-1500 mg)

Interventions/Control_2

control group

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patients with estimated glomerular filtration rates (eGFR) >=15 to 45 mL/min/1.73 m2 and serum phosphate levels >=4.0 mg/dL

patients with no acute change of renal function

Key exclusion criteria

1. Administration contraindication of ferric citrate
2. History of hypersensitivity to ferric citrate
3. Iron excess such as hemochromatosis
4. Uncontrolled diabetes mellitus; HbA1c >=9.0 % (NGSP)
5. Uncontrolled hypertension; systolic blood pressure >=170 mmHg or
diastolic blood pressure >=110 mmHg
6. Acute renal failure, nephrotic syndrome, dialysis, or renal transplantation
7. Complication or history of malignant tumor (not excluded from the study when the malignant tumor is not treated within 5 years and if there is no recurrence)
8. Pregnancy, nursing, or planned pregnancy during the study
9. Hormone replacement therapy with estrogens during the study
10. Intake of activated vitamin D or cinacalcet at the confirmation of eligibility
11. Ineligibility at the investigator's discretion

Target sample size

160

Name of lead principal investigator

1st name
Middle name
Last name	Shunya Uchida

Organization

Teikyo University School of Medicine

Division name

Department of Internal medicine

Zip code

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan

TEL

03-3964-1211

Email

s-uchida@med.teikyo-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shunya Uchida

Organization

Teikyo University School of Medicine

Division name

Department of Internal medicine

Zip code

Address

2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan

TEL

03-3964-1211

Homepage URL

Email

s-uchida@med.teikyo-u.ac.jp

Institute

Department of Internal medicine, Teikyo University School of Medicine

Institute

Department

Personal name

Organization

Torii Pharmaceutical Co., Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

帝京大学医学部附属病院(東京都)、上尾中央総合病院(埼玉県)、敬愛病院(東京都)、高島平中央総合病院(東京都)、東京北医療センター(東京都)、国立病院機構災害医療センター(東京都)、豊島中央病院(東京都)、練馬光が丘病院(東京都)、堀之内病院(埼玉県)、東京共済病院(東京都)、東京腎泌尿器センター大和病院(東京都)、JCHO 東京城東病院(東京都)、虎の門病院　分院(東京都)、東京逓信病院(東京都)、NTT東日本関東病院(東京都)、椎貝クリニック(茨城県)、埼玉医科大学総合医療センター(埼玉県)、イムス冨士見総合病院(埼玉県)、埼玉県立循環器・呼吸器病センター(埼玉県)、順天堂大学医学部附属順天堂医院(東京都)、杏林大学医学部付属病院(東京都)、立正佼成会附属佼成病院(東京都)、自治医科大学附属病院(栃木県)、帝京大学ちば総合医療センター(千葉県)

Date of disclosure of the study information

2016

Year

12

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2016

Year

03

Month

30

Day

Date of IRB

Anticipated trial start date

2016

Year

12

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

06

Day

Last modified on

2017

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028716