Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2015
Ferric pyrophosphate citrate (Triferic™) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Influence of intravenous iron therapy on mortality and cardiovascular events of patients on hemodialysis: A meta-analysis.Biomolecules & biomedicine · 2025Pooled it
- UK kidney association clinical practice guideline: update of anaemia of chronic kidney disease.BMC nephrology · 2025Guideline
- Infectious complications and mortality associated with the use of IV iron therapy: a systematic review and meta-analysis.International urology and nephrology · 2019Pooled it
- Pharmacokinetics and Safety of Ferric Pyrophosphate Citrate in Chinese Subjects with and without Hemodialysis-Dependent Stage 5 Chronic Kidney Disease.Drugs in R&D · 2022Trial
- Pharmacokinetics and Safety of Intravenous Ferric Pyrophosphate Citrate: Equivalence to Administration via Dialysate.Journal of clinical pharmacology · 2022Trial
- Pharmacokinetics of ferric pyrophosphate citrate administered via dialysate and intravenously to pediatric patients on chronic hemodialysis.Pediatric nephrology (Berlin, Germany) · 2018Trial
- Pharmacokinetics of Ferric Pyrophosphate Citrate, a Novel Iron Salt, Administered Intravenously to Healthy Volunteers.Journal of clinical pharmacology · 2017Trial
- Systematic Review of the Effects of Iron on Cardiovascular, Kidney, and Safety Outcomes in Patients With CKD.Kidney international reports · 2025Article
- Conventional and complementary alternative medicine therapies for renal anemia: a literature review.Frontiers in endocrinology · 2024Review
- Managing Anemia: Point of Convergence for Heart Failure and Chronic Kidney Disease?Life (Basel, Switzerland) · 2023Review
- Individualized anemia management enhanced by ferric pyrophosphate citrate protocol.Scientific reports · 2022Article
- Ethnicity evaluation of ferric pyrophosphate citrate among Asian and Non-Asian populations: a population pharmacokinetics analysis.European journal of clinical pharmacology · 2022Article
- Institutional Usage of Ferric Pyrophosphate Citrate (FPC) Delivered Via Dialysate in Reducing Erythropoiesis Stimulating Agents (ESAs) and IV Iron Cost.Hospital pharmacy · 2022Article
- Current Status of Renal Anemia Pharmacotherapy-What Can We Offer Today.Journal of clinical medicine · 2021Review
- Treatment of Iron Deficiency Anemia in CKD and End-Stage Kidney Disease.Kidney international reports · 2021Review
- Iron Therapy in Chronic Kidney Disease: Days of Future Past.International journal of molecular sciences · 2021Review
- Development and Clinical Application of Phosphorus-Containing Drugs.Medicine in drug discovery · 2020Review
- Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment.Journal of the American Society of Nephrology : JASN · 2020Review
- Ferric pyrophosphate citrate: interactions with transferrin.Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2018Article
- Physicochemical characterization of ferric pyrophosphate citrate.Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2018Article
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Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdministration of ferric pyrophosphate citrate (FPC, Triferic™) via hemodialysate may allow replacement of ongoing uremic and hemodialysis-related iron losses. FPC donates iron directly to transferrin, bypassing the reticuloendothelial system and avoiding iron sequestration.
methodsTwo identical Phase 3, randomized, placebo-controlled trials (CRUISE 1 and 2) were conducted in 599 iron-replete chronic hemodialysis patients. Patients were dialyzed with dialysate containing 2 µM FPC-iron or standard dialysate (placebo) for up to 48 weeks. Oral or intravenous iron supplementation was prohibited, and doses of erythropoiesis-stimulating agents were held constant. The primary efficacy end point was the change in hemoglobin (Hgb) concentration from baseline to end of treatment (EoT). Secondary end points included reticulocyte hemoglobin content (CHr) and serum ferritin.
resultsIn both trials, Hgb concentration was maintained from baseline to EoT in the FPC group but decreased by 0.4 g/dL in the placebo group (P < 0.001, combined results; 95% confidence interval [CI] 0.2-0.6). Placebo treatment resulted in significantly larger mean decreases from baseline in CHr (-0.9 pg versus -0.4 pg, P < 0.001) and serum ferritin (-133.1 µg/L versus -69.7 µg/L, P < 0.001) than FPC treatment. The proportions of patients with adverse and serious adverse events were similar in both treatment groups.
conclusionsFPC delivered via dialysate during hemodialysis replaces iron losses, maintains Hgb concentrations, does not increase iron stores and exhibits a safety profile similar to placebo. FPC administered by hemodialysis via dialysate represents a paradigm shift in delivering maintenance iron therapy to hemodialysis patients.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.