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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025161
Receipt No. R000028716
Scientific Title The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis
Date of disclosure of the study information 2016/12/16
Last modified on 2017/06/29

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Basic information
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
Condition hyperphosphatemia
chronic kidney disease (CKD)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Department of Internal medicine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Torii Pharmaceutical Co., Limited
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 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)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 16 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 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
Other related information

Management information
Registered date
2016 Year 12 Month 06 Day
Last modified on
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028716

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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