UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of PHOSPHate control On Renal function in chronic kidney disease patients not on dialysis
Title of the study (Brief title)	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	Shunya Uchida
Organization	Teikyo University School of Medicine
Division name	Department of Internal medicine
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	Shunya Uchida
Organization	Teikyo University School of Medicine
Division name	Department of Internal medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 03 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028716