A Phase 4 interventional study of Ferric Citrate 1 gram Oral Tablet and Standard of care phosphate-lowering therapy in Hyperphosphatemia, Anemia, Iron Deficiency and Renal Insufficiency, sponsored by USRC Kidney Research. Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by USRC Kidney Research · Phase 4, Interventional, and Treatment
This study is being conducted to demonstrate the effect of Auryxia, when used as the primary phosphate lowering therapy, on the overall cumulative use of erythropoiesis-stimulating agent and intravenous iron as well as on the laboratory parameters indicative of phosphate and anemia management.
Approximately 200 participants will be randomized 1:1 (stratified by modality and hemoglobin level) to receive either Auryxia or standard of care phosphate lowering therapy to determine the impact of Auryxia when used as the primary phosphate lowering therapy as compared to standard of care on the utilization of erythropoiesis-stimulating agent and intravenous iron in both in-center and home dialysis populations. This study will also seek to determine the impact of Auryxia, when used as the primary phosphate lowering therapy versus standard of care, on the biochemical assessments of serum phosphate and hemoglobin in both in-center and home dialysis populations.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's enrollment of 214 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →USRC Kidney Research is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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, (commercially available Auryxia), supplied as tablets for oral administration containing 1 gram ferric citrate (210 milligrams of ferric iron). Administered orally with meals or snacks.
Drug: Ferric Citrate 1 gram Oral Tablet
Non-Auryxia phosphate-lowering therapy administered as standard of care.
Drug: Standard of care phosphate-lowering therapy
Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
Also known as: Auryxia
Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
Difference in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups
Difference in change from baseline period (Month -3 to Day 1) to months 4 to 6 (efficacy evaluation period) in mean dose of erythropoiesis-stimulating agent (standardized Units per month) between Auryxia and standard of care treatment groups.
Time frame: Baseline period (Month -3 to Day 1) to months 4to 6 (efficacy evaluation period)
Difference in mean dose of intravenous iron (milligram per month) between Auryxia and standard of care treatment groups.
Difference in change from baseline period to efficacy evaluation period in mean dose of intravenous iron (milligrams per month) between Auryxia and standard of care treatment groups.
Time frame: Baseline period (Month -3 to Day 1) to months 4 to6 (efficacy evaluation period)
Difference in hemoglobin measurements
Difference in proportion of measurements with hemoglobin at or above 10.0 grams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period).
Difference in serum phosphate measurements
Difference in proportion of measurements with serum phosphate at or below 5.5 milligrams per deciliter between Auryxia and standard of care treatment groups during efficacy evaluation period.
Time frame: Baseline period (Month -3 to Day 1) to months 4to6 (efficacy evaluation period)
Ran from Jun 2021 to primary completion in Sep 2022, 14 months.
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Studies of the drug tested here: Tetraferric tricitrate decahydrate
USRC Kidney Research