UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025161 |
|---|---|
| Receipt number | 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 15:54:11 |
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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
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
s-uchida@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Internal medicine, Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028716
