Evidence map›Paper›PMID 18417741›Full record

Trial reportClinical journal of the American Society of Nephrology : CJASN2008

Pharmacokinetic and pharmacodynamic profiles of extended dosing of epoetin alfa in anemic patients who have chronic kidney disease and are not on dialysis.

Tracy McGowan, Nicole M Vaccaro, Jessica S Beaver, Joseph Massarella, Marsha Wolfson

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical journal of the American Society of Nephrology : CJASN, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 17% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. A randomized controlled study of weekly and biweekly dosing of epoetin alfa in CKD Patients with anemia.Clinical journal of the American Society of Nephrology : CJASN · 2009
    Trial
  9. Trial
  10. Article
  11. Anemia in chronic kidney disease.Pediatric nephrology (Berlin, Germany) · 2018
    Review
  12. Article
  13. Article
  14. Article
  15. Switch from epoetin to darbepoetin alfa in hemodialysis: dose equivalence and hemoglobin stability.International journal of nephrology and renovascular disease · 2014
    Article
  16. Article
  17. Article
  18. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Tracy McGowanOrtho Biotech Clinical Affairs, LLC, 430 Route 22 East, Bridgewater, NJ 08807, USA.
Nicole M Vaccaro
Jessica S Beaver
Joseph Massarella
Marsha Wolfson
Johnson & Johnson (United States) · USOrtho Clinical Diagnostics (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesEmerging evidence suggests that epoetin alfa can be administered at extended intervals of up to 4 wk. This open-label, randomized study was performed to characterize the pharmacokinetic and pharmacodynamic profiles of four dosing regimens of epoetin alfa administered subcutaneously in anemic patients who had chronic kidney disease and were not on dialysis. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Thirty-eight patients, enrolled from nine centers in the United States, were > or =18 yr of age and had hemoglobin <11.0 g/dl and GFR 12 to 60 ml/min per 1.73 m(2). Patients received one of four epoetin alfa dosing regimens: 50 IU/kg three times per week, 10,000 IU once weekly, or 20,000 IU every 2 wk for 36 d or 40,000 IU every 4 wk for 64 d. Each regimen provided a similar dosage of epoetin alfa over 4 wk. Dosage adjustments were not permitted.

resultsDrug exposure to epoetin alfa over 4 wk, based on area under the curve, was somewhat higher with the extended interval regimens compared with the three-times-weekly regimen. Mean change in hemoglobin during the study period was similar for all regimens. No patients were transfused. Three patients experienced five serious adverse events, none of which was considered treatment related.

conclusionsExtended dosing interval regimens of epoetin alfa yielded modest pharmacokinetic differences but a similar pharmacodynamic response, suggesting that less frequent, higher dosages of epoetin alfa may be as effective as the current three-times-weekly regimen in anemic patients who have chronic kidney disease and are not on dialysis.

Indexed as

AgedAged, 80 and overAnemiaChronic DiseaseDialysisDrug Administration ScheduleEpoetin AlfaErythrocyte CountErythropoietinFemaleHematinicsHemoglobinsHumansInjections, SubcutaneousKidney DiseasesMaleEpoetin AlfaErythropoietinHematinicsHemoglobinsRecombinant Proteins

Identifiers

PMID18417741
PMCPMC2440285
OpenAlexW2097391350

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.