THERAPY DOSSIER · th-3c849c617aa3

Continuous Erythropoietin Receptor Activator (CERA, methoxy polyethylene glycol-epoetin beta)

Biologic · Erythropoietin receptor agonist (AGONIST); continuous erythropoietin receptor activator

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Evidence & regulatory context

Mechanism: Erythropoietin receptor agonist (AGONIST); continuous erythropoietin receptor activator
Target: CHEMBL1817
Injury models: Chemical/toxin
Reported indication: Not recorded
First approval: 2007
Development stage: Not recorded
ChEMBL record: CHEMBL3707314 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: CERA; Mircera; Pegzerepoetin alfa; R-744
Note: Not recorded

Clinical trials 1

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT00442416 ↗PHASE3terminated

Monthly Mircera (methoxy PEG-epoetin beta) Versus Epoetin Alfa in Peritoneal Dialysis Patients

Anemia

Enrolment: 80 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 21968143 ↗2011Mixed findings

The effect of low-dose Continuous Erythropoietin receptor activator in an experimental model of acute Cyclosporine A induced renal injury.

RatChemical/toxinSprague-DawleyMalen = 12 rats, 6 per groupDescribed only as low dose; the numeric dose was not statedGiven during the 28-day period of cyclosporine A exposure

Model: Medium-dose cyclosporine A exposure for 28 days, producing acute renal tubulo-interstitial injury with macrophage sequestration and pancreatic islet cell damage

Cyclosporine A induced functional kidney damage that low-dose CERA did not improve. CERA showed a trend to osteopontin upregulation with increased renal macrophage infiltration and enhanced parenchymal transforming growth factor beta 1 and interleukin-10 relative to controls, and ameliorated pancre…

Extraction: extract · Supplied extraction confidence: 0.75. Machine-extracted fields require source verification.

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