Evidence map›Paper›PMID 26965694›Full record

ArticleAdvances in therapy2016

Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials.

Francesco Locatelli, Gabriel Choukroun, Matt Truman, Alfons Wiggenhauser, Danilo Fliser

13 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 20% 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.

NCT00413894 phase3completednot on this map

An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

TypeinterventionalSponsorHoffmann-La RocheRan2007 to 2008Enrolled424ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera]
NCT00517413 phase3completednot on this map

A Single-Arm Open-Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous and/or Subcutaneous C.E.R.A for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

TypeinterventionalSponsorHoffmann-La RocheRan2007 to 2010Enrolled163ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera]
NCT00545571 phase3completednot on this map

A Single Arm, Open Label, Interventional Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Hemoglobin Levels in Hemodialysis Patients With Chronic Renal Anemia

TypeinterventionalSponsorHoffmann-La RocheRan2007 to 2009Enrolled120ConditionsAnemiaArmsMethoxy polyethylene glycol-epoetin beta
NCT00550680 phase3completednot on this map

A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2009Enrolled208ConditionsChronic Renal AnemiaArmsMethoxy polyethylene glycol-epoetin beta
NCT00560404 phase3completednot on this map

A Randomized, Open Label Study to Compare the Effect of Once Monthly Administration of Subcutaneous Mircera Versus Epoetin Alfa on Maintenance of Hemoglobin Levels, Safety and Tolerability in Dialysis Patients With Chronic Renal Anemia.

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled233ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera], Epoetin alfa
NCT00576303 phase3completednot on this map

A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled200ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera]
NCT00605293 phase3completednot on this map

An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled101ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta, Epoetin alfa
NCT00642850 phase3completednot on this map

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

TypeinterventionalSponsorHoffmann-La RocheRan2007 to 2009Enrolled188ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera]
NCT00660023 phase3completednot on this map

A Single Arm, Open Label Study to Assess the Efficacy, Safety, and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled124ConditionsAnemiaArmsMethoxy polyethylene glycol-epoetin beta
NCT00661505 phase3completednot on this map

A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Haemodialysis Patients With Chronic Renal Anaemia.

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled132ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta
NCT00699348 phase3completednot on this map

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2010Enrolled351ConditionsAnemiaArmsMethoxy polyethylene glycol-epoetin beta (C.E.R.A.)
NCT00717821 phase3completednot on this map

A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis

TypeinterventionalSponsorHoffmann-La RocheRan2008 to 2011Enrolled421ConditionsAnemiaArmsMethoxy Polyethylene Glycol-epoetin Beta, Epoetin Beta, Darbepoetin Alfa
NCT00882713 phase3completednot on this map

A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

TypeinterventionalSponsorHoffmann-La RocheRan2009 to 2010Enrolled202ConditionsAnemiaArmsmethoxy polyethylene glycol-epoetin beta [Mircera]
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
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

5 authors at 4 institutions in 3 countries.

Francesco LocatelliNephrology, Dialysis and Transplantation Department, Alessandro Manzoni Hospital, Lecco, Italy. f.locatelli@ospedale.lecco.it.
Gabriel ChoukrounNephrology, Dialysis and Transplantation Department, CHU Amiens and University of Picardie Jules Verne, Amiens, France.
Matt TrumanRoche Australia, Dee Why, Australia.
Alfons WiggenhauserRoche Pharma AG, Medical Affairs, Grenzach-Wyhlen, Germany.
Danilo FliserDepartment of Internal Medicine IV, Saarland University Medical Centre, Homburg/Saar, Germany.
Alessandro Manzoni Hospital · ITRoche Pharma AG (Germany) · DESaarland University · DEUniversité de Picardie Jules Verne · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionErythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney disease population are maintained in specific subgroups.

methodsData from 13 Phase III trials set up with similar design were retrospectively pooled for this analysis. Patients with chronic kidney disease who had previously been receiving epoetin or darbepoetin were switched to continuous erythropoiesis receptor activator once-monthly after a 4- to 8-week screening period. Patients entered a 16-week continuous erythropoiesis receptor activator dose-titration period followed by an 8-week evaluation period. In total, 2060 patients were included in the analysis. Subgroups were defined based on: hemoglobin target range [lower (10.0-12.0 g/dL)/upper (10.5-13.0 g/dL)], gender (female/male), age (<65/≥65), baseline N-terminal pro-B-type natriuretic peptide levels (<5000/≥5000), cardiovascular risk factors (diabetes/cardiac/vascular/none).

resultsAcross all subgroups analyzed, switching from shorter-acting erythropoiesis-stimulating agents to continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin concentrations in a high proportion of patients (78%), with only moderate hemoglobin fluctuations and a low number of dose changes. The safety profile across subgroups was as expected based on pre-existing risk factors; observed increases in adverse events were attributable to underlying risk factors rather than study drug.

conclusionsThis retrospective analysis of 13 trials showed that continuous erythropoiesis receptor activator once-monthly maintained stable hemoglobin levels across a number of clinically relevant patient subgroups, including those with higher inherent cardiovascular risk. The safety profile was consistent with that previously established in the chronic kidney disease population. CLINICALTRIALS. GOV IDENTIFIERS: NCT00413894/NCT00545571/NCT00517413/NCT00560404/NCT00882713/NCT00550680/NCT00576303/NCT00660023/NCT00717821/NCT00642850/NCT00605293/NCT00661505/NCT00699348.

fundingF. Hoffmann-La Roche Ltd, Basel, Switzerland.

Indexed as

AnemiaClinical Trials, Phase III as TopicRandomized Controlled Trials as TopicRenal DialysisRenal Insufficiency, ChronicAgedDose-Response Relationship, DrugErythropoietinFemaleHematinicsHemoglobinsHumansMaleMiddle AgedOutcome and Process Assessment, Health CarePolyethylene Glycolscontinuous erythropoietin receptor activatorErythropoietinHematinicsHemoglobinsPolyethylene GlycolsAnemia, chronic kidney diseaseContinuous erythropoiesisEfficacyHemodialysisPatient subgroupsPooled analysisReceptor activator

Identifiers

PMID26965694
PMCPMC4846713
OpenAlexW2293315172

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 7 more above

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.