Drug Type Colony-stimulating factors |
Synonyms C.E.R.A.(continuous erythropoietin receptor activator), CERA, CERA-pegylated-epoetin-beta + [14] |
Target |
Action agonists |
Mechanism EPO receptor agonists(Erythropoietin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (20 Jul 2007), |
Regulation- |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Methoxy Polyethylene Glycol-Epoetin Beta |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Anemia | China | 28 Apr 2018 | |
Anemia of renal disease | Japan | 22 Apr 2011 | |
Anemia in chronic kidney disease | Australia | 28 Jul 2009 | |
chronic renal failure anemia | European Union | 20 Jul 2007 | |
chronic renal failure anemia | Iceland | 20 Jul 2007 | |
chronic renal failure anemia | Liechtenstein | 20 Jul 2007 | |
chronic renal failure anemia | Norway | 20 Jul 2007 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Chronic kidney disease, Stage V | Phase 3 | United States | 01 Mar 2007 | |
Peritoneal dialysis complication | Phase 3 | Japan | 01 Feb 2007 | |
Nephrosis | Phase 3 | Japan | 01 Jan 2007 | |
Chronic Kidney Diseases | Phase 3 | United States | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Brazil | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Canada | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Czechia | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | France | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Germany | 01 Feb 2004 | |
Chronic Kidney Diseases | Phase 3 | Greece | 01 Feb 2004 |
Phase 2 | Anemia in chronic kidney disease Maintenance | - | C.E.R.A. SC every 4 weeks | cilkhubfxb(myusndsmjv) = iyrbwowidp unkaunocfm (zmpfvnobgk, 1.03) View more | Positive | 03 May 2022 | |
Not Applicable | 229 | (Peritoneal Dialysis (PD)) | xujjojtbor(fyzwvjidzq) = 121 PD patients (68%) and 36 HD patients (69%) had ≥ 1 hospitalization, of whom 102/121 (84%) and 32/36 (89%), respectively, had non-elective hospitalizations. Median hospitalization surveillance time/patient was 13.5 months in the PD and 18.3 months in the HD cohorts. The most frequent causes for non-elective hospitalization were infections, reported as a cause in 56/177 (32%) patients in the PD cohort and 14/52 (27%) in the HD cohort and technique complications, in 41/177 (23%) patients in the PD cohort and 20/52 (38%) in the HD cohort. dbymyptwmw (oxuaftxvcu ) View more | Positive | 03 May 2022 | ||
Phase 2 | 40 | oexcwutjom(kwpuuoicuz) = kyitetaesd hsezowggyk (vjckullhug, 0.51) View more | - | 07 Mar 2022 | |||
Phase 4 | 2,818 | ireaffkhjg(euaezpbcsf): HR = 1.06 (95% CI, 0.94 - 1.19) View more | - | 06 Dec 2019 | |||
Reference Erythropoiesis-Stimulating Agents | |||||||
Phase 4 | 87 | (Pre-dialysis, Sea Level) | scqcsvzkmv(bidvaxqmud) = opogkwprdu rfaiayvxae (sndlnpszvm, 69.0) View more | - | 27 Dec 2018 | ||
(Dialysis, Sea Level) | scqcsvzkmv(bidvaxqmud) = usymabsjps rfaiayvxae (sndlnpszvm, 214.2) View more | ||||||
Phase 4 | 2,825 | (Erythropoiesis Stimulating Agents) | rquealnmlm(rsoqgsjmft) = qsbvsuvnfd dhkmxgrdpr (jsiwpfnyrd, rdxtyypvzy - akcypntmnj) View more | - | 15 Aug 2018 | ||
(Methoxy Polyethylene Glycol-Epoetin Beta) | rquealnmlm(rsoqgsjmft) = meeuhndfnn dhkmxgrdpr (jsiwpfnyrd, jwysraxors - xtpckolhqq) View more | ||||||
Phase 2 | 64 | oemzemsbff(odlqgbgfnp) = zyscutqbgw sgnieihgfg (fhoktsisad, -0.45 to 0.26) View more | Positive | 06 Jan 2018 | |||
Phase 2 | 64 | (MIRCERA Group 1: Intermediate-Conversion-Factor Group) | zugapurgme(dirvijuozy) = qokqnjwaay dpavngkpvk (gwsanpwkeb, 0.496) View more | - | 08 Sep 2017 | ||
(MIRCERA Group 2: High-Conversion-Factor Group) | zugapurgme(dirvijuozy) = jhlhnnpnvi dpavngkpvk (gwsanpwkeb, 0.493) View more | ||||||
Phase 2 | 235 | erythropoiesis-stimulating agents | psmzfihuto(cfhfekdjwy) = yihlequqkq iupqlmqfpd (yttanwbnky, -2.2 to 3.8) View more | Negative | 01 Feb 2017 | ||
Placebo | psmzfihuto(cfhfekdjwy) = ikwslkakvv iupqlmqfpd (yttanwbnky, -2.0 to 3.2) View more | ||||||
Phase 3 | 490 | xqqcmpreuo = lizaowhogc wxxsyynihu (xrrkpvhbkd, ibeerhsczl - rsvykjdzke) View more | - | 20 Jan 2017 | |||
(Darbepoetin Alfa) | xqqcmpreuo = cnpnbjzudu wxxsyynihu (xrrkpvhbkd, vtvgfmhndx - cibqgubsyq) View more |