Status:
COMPLETED
Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
Lead Sponsor:
Panion & BF Biotech Inc.
Conditions:
Kidney Failure, Chronic
End-stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
Detailed Description
This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.
Eligibility Criteria
Inclusion
- Is ≧ 18 years of age on the day of signing informed consent or other age required by local regulation
- Willing and able to provide written informed consent
- ESRD patients who is undergoing hemodialysis 3 times per week and is considered necessary to receive medication for hyperphosphatemia by his/her treating physician
- Serum ferritin \<1000 ng/mL and transferrin saturation (TSAT) \< 50% at the Enrollment Visit
- 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
- 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
- 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
- Has participated in another interventional study for any investigational agent or device within 30 days prior to enrollment
- Is currently pregnant or breastfeeding
- Other unstable medical condition or psychiatric conditions that is considered unsuitable for this study per Investigator's clinical judgment
Key Trial Info
Start Date :
April 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03256838
Start Date
April 12 2017
End Date
May 31 2019
Last Update
January 13 2020
Active Locations (9)
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1
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
2
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
3
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 20401
4
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, Taiwan, 22060