Clinical Trials List
2017-01-01 - 2018-12-31
Phase IV
Terminated9
ICD-10N18
Chronic kidney disease (CKD)
ICD-10N18.6
End stage renal disease
A Long-Term, Open-Label, Prospective Observational Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects with End Stage Renal Disease (ESRD) on Dialysis.
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Trial Applicant
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Sponsor
Panion & BF Biotech Inc.
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 張瑞廷 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃惠勇 Division of Nephrology
- Chien-Hsing Wu Division of Nephrology
- 邱鼎育 Division of Nephrology
- 楊智超 Division of Nephrology
- 李岳庭 Division of Nephrology
- Wen-Chin Lee Division of Nephrology
- 郭韋宏 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Hsi-Hsien Chen Division of Nephrology
- Chih-Chin Kao Division of Nephrology
- Yen-Chung Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 楊智宇 Division of Nephrology
- 歐朔銘 Division of Nephrology
- Yao-Ping Lin Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- SHUEI-LIONG LIN Division of Nephrology
- 楊紹佑 Division of Nephrology
- Jenq-Wen Huang Division of Nephrology
- - - Division of Nephrology
- WEN-CHIH CHIANG Division of Nephrology
- 朱宗信 Division of Nephrology
- VIN-CENT Wu Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Number of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 13 months ]
Number of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs) [ Time Frame: 13 months ]
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures :
Serum Phosphorus [ Time Frame: 13 months ]
Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (>=3.5 mg/dL and <=5.5. mg/dL) from baseline to the end-of-treatment.
Other Outcome Measures:
Serum calcium [ Time Frame: 13 months ]
Time-course changes of serum calcium from baseline.
Intact plasma parathyroid hormone (iPTH) [ Time Frame: 13 months ]
Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.
Ferritin [ Time Frame: 13 months ]
Time-course changes of ferritin from baseline.
Transferring saturation (TSAT) percentage [ Time Frame: 13 months ]
Time-course changes of transferring saturation (TSAT) percentage from baseline.
Serum iron [ Time Frame: 13 months ]
Time-course changes of serum iron from baseline.
Total iron-binding capacity (TIBC) [ Time Frame: 13 months ]
Time-course changes of total iron-binding capacity (TIBC) from baseline.
Hemoglobin [ Time Frame: 13 months ]
Time-course changes of hemoglobin from baseline.
Dose of IV iron [ Time Frame: 13 months ]
Time-course changes of dose of IV iron from baseline.
Dose of erythropoiesis stimulating agents (ESA) [ Time Frame: 13 months ]
Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.
Treatment adherence [ Time Frame: 13 months ]
Prescribed dose and the dose actually taken at each time point will be calculated.
Inclution Criteria
1.Is ≧18 years of age on the day of signing informed consent or other age required by local regulation
2.Willing and able to provide written informed consent
3.ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
4.Serum ferritin <1000 ng/mL and transferrin saturation (TSAT) < 50% at the Enrollment Visit
5.Women of child-bearing potential (WOCBP [defined as women ≦ 50 years of age with a history of amenorrhea for < 12 months prior to study entry]) who is willing to use an effective form of contraception during study participation.
Exclusion Criteria
1.Has any known contraindication to ferric citrate according to locally approved prescribing information, include but not limited to the following criteria:
i.Is allergic to ferric citrate
ii.Has hypophosphatemia
iii.Has hemochromatosis or iron overload syndromes
iv.Has active severe GI disorders
2.Has parathyroidectomy (PTx) or percutaneous ethanol injection therapy (PEIT) within 3 months prior to Enrollment Visit or serum calcium < 7 mg/dL at the Enrollment Visit
3.Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
4.Is currently pregnant or breastfeeding
5.Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator’s clinical judgment
The Estimated Number of Participants
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Taiwan
200 participants
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Global
0 participants
