Last reviewed · How we verify
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Phase 4 trial testing Ferric Citrate in Hyperphosphatemia in 55 participants. Completed in 14 September 2019.
| Lead sponsor | Kaiser Permanente |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 55 |
| Start date | 1 May 2017 |
| Primary completion | 14 September 2019 |
| Estimated completion | 14 September 2019 |
| Sites | 1 location across United States |
Kaiser Permanente — full company profile →
Eligibility, any sex, with Hyperphosphatemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 5.3 | ± 1 |
| Ferric Citrate - Peritoneal Dialysis | 5.6 | ± 0.8 |
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 5.4 | ± 1.1 |
| Ferric Citrate - Peritoneal Dialysis | 6 | ± 1.8 |
The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 249.2 | ± 215.6 |
| Ferric Citrate - Peritoneal Dialysis | 21.2 | ± 43.1 |
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 102 | ± 137.5 |
| Ferric Citrate - Peritoneal Dialysis | 11.6 | ± 33.7 |
Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 28761.1 | ± 41314.1 |
| Ferric Citrate - Peritoneal Dialysis | 16724.4 | ± 14042.3 |
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 16525.8 | ± 16917 |
| Ferric Citrate - Peritoneal Dialysis | 16780.1 | ± 13433.7 |
median pill count of ferric citrate pills/day required to maintain phosphorus control
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 9.5 | 6.8 – 13.8 |
| Ferric Citrate - Peritoneal Dialysis | 6 | 6.0 – 9.0 |
| Group | Value | 95% CI |
|---|---|---|
| Ferric Citrate - Hemodialysis | 6.0 | 4.5 – 9.0 |
| Ferric Citrate - Peritoneal Dialysis | 4.5 | 2.0 – 6.0 |
Time frame: 7 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ferric Citrate - Hemodialy… | Ferric Citrate - Peritonea… |
|---|---|---|---|
| Arteriovenous fistula | Blood and lymphatic system disorders | — | — |
| Congestive heart failure exacerbation | Cardiac disorders | — | — |
| gallstone pancreatitis | Gastrointestinal disorders | — | — |
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | — | — |
| Hematochezia | Gastrointestinal disorders | — | — |
| Abdominal swelling | General disorders | — | — |
| Peritonitis | General disorders | — | — |
| Right foot infection | Infections and infestations | — | — |
| Chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Chronic back pain | Musculoskeletal and connective tissue disorders | — | — |
| Intertrochanteric fracture | Musculoskeletal and connective tissue disorders | — | — |
| Left foot pain | Musculoskeletal and connective tissue disorders | — | — |
| Right hip osteoporotic Fracture | Musculoskeletal and connective tissue disorders | — | — |
| Laparoscopic right nephrectomy | Renal and urinary disorders | — | — |
| Placement of catheter for HD | Renal and urinary disorders | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| Right sided pleuroperitoneal leak | Respiratory, thoracic and mediastinal disorders | — | — |
| Left heel ulcers | Skin and subcutaneous tissue disorders | — | — |
| Critical limb ischemia | Vascular disorders | — | — |
| Hemorrhagic cerebrovascular accident | Vascular disorders | — | — |
| Peripheral vascular disease | Vascular disorders | — | — |
| Reaction | System | Ferric Citrate - Hemodialy… | Ferric Citrate - Peritonea… |
|---|---|---|---|
| Black stool | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea, vomiting | Gastrointestinal disorders | — | — |
| Itching/rash | Skin and subcutaneous tissue disorders | — | — |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Bloating/Gas | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Urinary Tract Infection | Renal and urinary disorders | — | — |
| Abscess | Infections and infestations | — | — |
| Peritonitis | General disorders | — | — |
| Chest Pain/Palpitations | Cardiac disorders | — | — |
Most-reported serious reactions: Arteriovenous fistula, Congestive heart failure exacerbation, gallstone pancreatitis, Gastrointestinal Hemorrhage, Hematochezia, Abdominal swelling, Peritonitis, Right foot infection.
Data from ClinicalTrials.gov NCT03079869 adverse events section.
Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03079869.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing