End-stage Renal Disease, Hyperphosphatemia, Kidney Failure, Chronic, Phosphorus Metabolism Disorders
Conditions
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
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.
Interventions
DRUGFerric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Sponsors
Panion & BF Biotech Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with treatment-emergent adverse events (TEAEs) | 13 months | Number of subjects with treatment-emergent adverse events (TEAEs) |
| Percentage of subjects with treatment-emergent adverse events (TEAEs) | 13 months | Percentage of subjects with treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphorus | 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
| Measure | Time frame | Description |
|---|---|---|
| Transferring saturation (TSAT) percentage | 13 months | Time-course changes of transferring saturation (TSAT) percentage from baseline. |
| Serum iron | 13 months | Time-course changes of serum iron from baseline. |
| Total iron-binding capacity (TIBC) | 13 months | Time-course changes of total iron-binding capacity (TIBC) from baseline. |
| Serum calcium | 13 months | Time-course changes of serum calcium from baseline. |
| Dose of IV iron | 13 months | Time-course changes of dose of IV iron from baseline. |
| Dose of erythropoiesis stimulating agents (ESA) | 13 months | Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline. |
| Treatment adherence | 13 months | Prescribed dose and the dose actually taken at each time point will be calculated. |
| Hemoglobin | 13 months | Time-course changes of hemoglobin from baseline. |
| Intact plasma parathyroid hormone (iPTH) | 13 months | Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline. |
| Ferritin | 13 months | Time-course changes of ferritin from baseline. |
Countries
Taiwan
Outcome results
None listed