A Phase 4 interventional study of Ferric Citrate in Kidney Failure, Chronic, End-stage Renal Disease and Phosphorus Metabolism Disorders, sponsored by Panion & BF Biotech Inc.. Completed at 9 sites in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Panion & BF Biotech Inc. · Phase 4, Interventional, and Other
To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 202 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Panion & BF Biotech Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Has any known 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ferric Citrate (Nephoxil® Capsules) will be dosed three times a day (with meals).
Drug: Ferric Citrate
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Also known as: Nephoxil® Capsules
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Serum Phosphorus
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.
Time frame: 13 months
Serum calcium
Time-course changes of serum calcium from baseline.
Time frame: 13 months
Intact plasma parathyroid hormone (iPTH)
Time-course changes of intact plasma parathyroid hormone (iPTH) from baseline.
Time frame: 13 months
Ferritin
Time-course changes of ferritin from baseline.
Time frame: 13 months
Transferring saturation (TSAT) percentage
Time-course changes of transferring saturation (TSAT) percentage from baseline.
Time frame: 13 months
Serum iron
Time-course changes of serum iron from baseline.
Time frame: 13 months
Total iron-binding capacity (TIBC)
Time-course changes of total iron-binding capacity (TIBC) from baseline.
Time frame: 13 months
Hemoglobin
Time-course changes of hemoglobin from baseline.
Time frame: 13 months
Dose of IV iron
Time-course changes of dose of IV iron from baseline.
Time frame: 13 months
Dose of erythropoiesis stimulating agents (ESA)
Time-course changes of dose of erythropoiesis stimulating agents (ESA) from baseline.
Time frame: 13 months
Treatment adherence
Prescribed dose and the dose actually taken at each time point will be calculated.
Time frame: 13 months
Plan to share: No
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ferric citrate
Panion & BF Biotech Inc.