Clinical trial NCT03256838: Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
Official title: A Long-Term, Open-Label, Prospective Phase IV Study to Assess the Safety and Efficacy of Nephoxil® in Subjects With End Stage Renal Disease (ESRD) on Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
End-stage Renal Disease
Phosphorus Metabolism Disorders
Hyperphosphatemia
Keywords: Citric Acid
Ferric Compounds
Renal Insufficiency
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Hemodialysis
Dialysis
Renal Failure
Kidney Failure
Urologic Diseases
Metabolic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Lead sponsor: Panion & BF Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 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

Primary outcomes:
measure: Number of subjects with treatment-emergent adverse events (TEAEs)
timeFrame: 13 months
measure: Percentage of subjects with treatment-emergent adverse events (TEAEs)
timeFrame: 13 months
Secondary outcomes:
measure: Serum Phosphorus
timeFrame: 13 months
Other outcomes:
measure: Serum calcium
timeFrame: 13 months
measure: Intact plasma parathyroid hormone (iPTH)
timeFrame: 13 months
measure: Ferritin
timeFrame: 13 months
measure: Transferring saturation (TSAT) percentage
timeFrame: 13 months
measure: Serum iron
timeFrame: 13 months
measure: Total iron-binding capacity (TIBC)
timeFrame: 13 months
measure: Hemoglobin
timeFrame: 13 months
measure: Dose of IV iron
timeFrame: 13 months
measure: Dose of erythropoiesis stimulating agents (ESA)
timeFrame: 13 months
measure: Treatment adherence
timeFrame: 13 months
Locations:
city: Kaohsiung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
city: Keelung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
city: Taichung
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
city: Taipei
country: Taiwan
facility: Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
name: Mai-Szu Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee CT, Lee CC, Wu MJ, Chiu YW, Leu JG, Wu MS, Peng YS, Wu MS, Tarng DC. Long-term safety and efficacy of ferric citrate in phosphate-lowering and iron-repletion effects among patients with on hemodialysis: A multicenter, open-label, Phase IV trial. PLoS One. 2022 Mar 3;17(3):e0264727. doi: 10.1371/journal.pone.0264727. eCollection 2022.