Evidence map›Paper›PMID 24408120›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2014

Ferric citrate hydrate for the treatment of hyperphosphatemia in nondialysis-dependent CKD.

Keitaro Yokoyama, Hideki Hirakata, Takashi Akiba, Masafumi Fukagawa, Masaaki Nakayama, Kenichi Sawada, Yuji Kumagai, Geoffrey A Block

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 68 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 8 pooled it
10.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 8 syntheses or guidelines pooled it, 127 citations in OpenAlex.

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  14. Effects of sucroferric oxyhydroxide and sevelamer carbonate on chronic kidney disease-mineral bone disorder parameters in dialysis patients.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2019
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  17. Randomized Clinical Trial of Sevelamer Carbonate on Serum Klotho and Fibroblast Growth Factor 23 in CKD.Clinical journal of the American Society of Nephrology : CJASN · 2017
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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 8 institutions in 2 countries.

Keitaro YokoyamaDivision of Kidney and Hypertension, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan;, †Japanese Red Cross, Fukuoka Hospital, Fukuoka, Japan;, ‡Department of Blood Purification, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan;, §Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan;, ‖Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism, Fukushima Medical University School of Medicine, Fukushima, Japan;, ¶Department of Hematology, Nephrology and Rheumatology, Akita University, Akita, Japan;, *Kitasato University East Hospital Clinical Trial Center, Sagamihara, Japan, ††Denver Nephrologists, PC, Denver, Colorado.
Hideki Hirakata
Takashi Akiba
Masafumi Fukagawa
Masaaki Nakayama
Kenichi Sawada
Yuji Kumagai
Geoffrey A Block
Akita University · JPColorado Kidney Care · USFukushima Medical University · JPJapanese Red Cross Fukuoka Hospital · JPJikei University School of Medicine · JPKitasato University Hospital · JPTokai University · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesFerric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A phase 3, multicenter, randomized, double blind, placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD. Starting in April of 2011, 90 CKD patients (eGFR=9.21±5.72 ml/min per 1.73 m(2)) with a serum phosphate≥5.0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks. The primary end point was change in serum phosphate from baseline to the end of treatment. Secondary end points included the percentage of patients achieving target serum phosphate levels (2.5-4.5 mg/dl) and change in fibroblast growth factor-23 at the end of treatment.

resultsThe mean change in serum phosphate was -1.29 mg/dl (95% confidence interval, -1.63 to -0.96 mg/dl) in the ferric citrate hydrate group and 0.06 mg/dl (95% confidence interval, -0.20 to 0.31 mg/dl) in the placebo group (P<0.001 for difference between groups). The percentage of patients achieving target serum phosphate levels was 64.9% in the ferric citrate hydrate group and 6.9% in the placebo group (P<0.001). Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo (change from baseline [median], -142.0 versus 67.0 pg/ml; P<0.001). Ferric citrate hydrate significantly increased serum iron, ferritin, and transferrin saturation compared with placebo (P=0.001 or P<0.001). Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo. Overall, adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo, with gastrointestinal disorders occurring in 30.0% of ferric citrate hydrate patients and 26.7% of patients receiving placebo.

conclusionIn patients with nondialysis-dependent CKD, 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters.

Indexed as

AgedBiomarkersChelating AgentsDouble-Blind MethodFemaleFerric CompoundsFerritinsFibroblast Growth Factor-23Fibroblast Growth FactorsHumansHyperphosphatemiaIronJapanMaleMiddle AgedPhosphatesBiomarkersChelating Agentsferric citrateFerric CompoundsFerritinsFibroblast Growth Factor-23Fibroblast Growth FactorsIronPhosphatesTransferrin

Identifiers

PMID24408120
PMCPMC3944759
OpenAlexW2163181937

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.