Phase 4
N=55
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT03079869 ↗Enrolled (actual)
55
Serious AEs
31.5%
Results posted
Jan 2022
Primary outcome: Primary: Phosphorus Levels — 5.3; 5.6; 5.4; 6 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ferric Citrate (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Kaiser Permanente
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phosphorus Levels |
5.3; 5.6; 5.4; 6 | — |
| SECONDARY Intravenous (IV) Iron |
249.2; 21.2; 102; 11.6 | — |
| SECONDARY Erythropoiesis Stimulating Agents (ESA) Dose |
28761.1; 16724.4; 16525.8; 16780.1 | — |
| SECONDARY Median Pill Count |
9.5; 6; 6.0; 4.5 | — |
Summary
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
Eligibility Criteria
Inclusion Criteria
- Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate
- Mean serum phosphorus 4.0- 8.0 mg/dl for 6 months prior to enrollment
- Mean PTH < 1000 pg/ml for 6 months prior to enrollment
- Mean ferritin < 1500 ng/ml and mean iron sat < 50% for 6 months prior to enrollment
Exclusion Criteria
- History of gastrointestinal bleeding within past 6 months
- History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months
- Acute kidney injury equal to or less than 3 months before the initial screening date
- Active malignancy
- Functioning renal transplant
- Patients with iron overload syndrome (e.g., Hemochromatosis)
- History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease
- Active or past history of calciphylaxis
Data sourced from ClinicalTrials.gov (NCT03079869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.