PMID- 25327065
OWN - NLM
STAT- MEDLINE
DCOM- 20141103
LR  - 20181202
IS  - 0004-5772 (Print)
IS  - 0004-5772 (Linking)
VI  - 62
IP  - 3
DP  - 2014 Mar
TI  - A single arm, prospective, open label, multicentre study for evaluation of 
      efficacy and safety of IV CERA for treatment of chronic renal anaemia in dialysis 
      patients not currently treated with ESA.
PG  - 232-6
AB  - INTRODUCTION: CERA, a continuous erythropoietin receptor activator, has reported 
      effective correction of anaemia in international clinical trials. OBJECTIVE: 
      Objective of this study was to evaluate efficacy and safety of CERA in Indian 
      patients who were on dialysis and has not received erythropoiesis stimulating 
      agent (ESA) therapy in last 8 weeks. METHODS: In this open label, single arm, 
      prospective, multi-centre study, 189 patients on dialysis, having Haemoglobin 
      (Hb) between 8 - 10 g/dL and not receiving any ESA for last 8 weeks were included 
      at 14 centers across India. CERA was given intravenous (IV) at the dose of 0.6 
      microg/kg every two weeks. Primary end point of the study was mean change in Hb 
      concentration from baseline to end of the treatment period (TP) of 16 weeks. 
      RESULTS: Mean change of Hb from baseline to end of TP was 2.11 +/- 1.37 g/dL and 
      2.08 +/- 1.29 g/dL in intent to treat (ITT) and per protocol (PP) population 
      respectively. Mean time to achieve Hb response was 6.10 +/- 3.87 weeks and 6.16 
      +/- 3.92 weeks in ITT and PP populations respectively. Out of 68 adverse events 
      (AEs) seen during study period, 33 were serious adverse events (SAEs). As per 
      investigators all SAEs were related to underlying disease and not to the study 
      medication. CONCLUSION: It is concluded that CERA administered once in two weeks 
      in dialysis patients effectively corrected chronic kidney disease (CKD) related 
      anaemia and was well tolerated with no significant untoward effect directly 
      related to drug therapy in Indian population.
FAU - Nainan, Georgy K
AU  - Nainan GK
FAU - Pathak, Vivek R
AU  - Pathak VR
FAU - Dalal, Sonal S
AU  - Dalal SS
FAU - Saxena, Sanjiv
AU  - Saxena S
FAU - Mittal, Dinesh
AU  - Mittal D
FAU - Raju, T Ravi
AU  - Raju TR
FAU - Gokulnath
AU  - Gokulnath
FAU - Isaac, Rajan
AU  - Isaac R
FAU - Rajapurkar, M M
AU  - Rajapurkar MM
FAU - Rana, D S
AU  - Rana DS
FAU - Shah, Bharat V
AU  - Shah BV
FAU - Ray, Deepak S
AU  - Ray DS
FAU - Thiagarajan, C M
AU  - Thiagarajan CM
FAU - Jha, Ratan M
AU  - Jha RM
FAU - Kukreja, Anil A
AU  - Kukreja AA
FAU - Pophale, Rupesh R
AU  - Pophale RR
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - J Assoc Physicians India
JT  - The Journal of the Association of Physicians of India
JID - 7505585
RN  - 0 (continuous erythropoietin receptor activator)
RN  - 11096-26-7 (Erythropoietin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Administration, Intravenous
MH  - Adult
MH  - Anemia/*drug therapy/etiology
MH  - Drug Administration Schedule
MH  - Erythropoietin/*therapeutic use
MH  - Female
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - Polyethylene Glycols/*therapeutic use
MH  - Prospective Studies
MH  - *Renal Dialysis
MH  - Renal Insufficiency, Chronic/complications/*therapy
MH  - Treatment Outcome
EDAT- 2014/10/21 06:00
MHDA- 2014/11/05 06:00
CRDT- 2014/10/21 06:00
PHST- 2014/10/21 06:00 [entrez]
PHST- 2014/10/21 06:00 [pubmed]
PHST- 2014/11/05 06:00 [medline]
PST - ppublish
SO  - J Assoc Physicians India. 2014 Mar;62(3):232-6.