PMID- 32651955
OWN - NLM
STAT- MEDLINE
DCOM- 20211125
LR  - 20211125
IS  - 1460-2385 (Electronic)
IS  - 0931-0509 (Print)
IS  - 0931-0509 (Linking)
VI  - 36
IP  - 8
DP  - 2021 Jul 23
TI  - Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of 
      hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, 
      Phase IIb study in patients with haemodialysis-dependent chronic kidney disease.
PG  - 1399-1407
LID - 10.1093/ndt/gfaa116 [doi]
AB  - BACKGROUND: Hyperphosphataemia is a common complication of chronic kidney disease 
      (CKD). PT20 (ferric iron oxide adipate) is an investigational molecule engineered 
      to offer enhanced phosphate-binding properties relative to other phosphate 
      binders. METHODS: In this double-blind, parallel-group, placebo-controlled, 
      dose-ranging study (ClinicalTrials.gov identifier NCT02151643), the efficacy and 
      safety of 28 days of oral PT20 treatment were evaluated in patients with 
      dialysis-dependent CKD. Participants were randomly assigned in an 8:8:8:13:13 
      ratio to receive PT20 (400, 800, 1600 or 3200 mg) or placebo three times daily. 
      RESULTS: Among 153 participants, 129 completed treatment [7 discontinued because 
      of adverse events (AEs), 2 because of hyperphosphataemia and 15 for other 
      reasons]. PT20 treatment for 28 days resulted in a statistically significant and 
      dose-dependent reduction in serum phosphate concentration. There were no 
      statistically significant effects of PT20 treatment on changes in haemoglobin or 
      ferritin concentrations or transferrin saturation between Days 1 and 29. The 
      incidence of treatment-emergent AEs was broadly similar across the PT20 and 
      placebo groups (42-59% versus 44%). The most common PT20 treatment-related AEs 
      were gastrointestinal, primarily diarrhoea (13-18%) and discoloured faeces 
      (3-23%). No serious AEs were considered to be related to study treatment. There 
      were no clinically significant changes in laboratory results reflecting acid/base 
      status or increases in ferritin that could indicate the absorption of components 
      of PT20. CONCLUSIONS: In this first study investigating the efficacy and safety 
      of PT20 in patients with hyperphosphataemia and dialysis-dependent CKD, PT20 
      significantly lowered serum phosphate concentrations and was generally well 
      tolerated.
CI  - (c) The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA. 
      All rights reserved.
FAU - Sampson, Mark
AU  - Sampson M
AD  - Shield Therapeutics PLC, London, UK.
FAU - Faria, Nuno
AU  - Faria N
AD  - Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.
AD  - Medical Research Council Elsie Widdowson Laboratory, Cambridge, UK.
FAU - Powell, Jonathan J
AU  - Powell JJ
AD  - Department of Veterinary Medicine, University of Cambridge, Cambridge, UK.
AD  - Medical Research Council Elsie Widdowson Laboratory, Cambridge, UK.
CN  - PEACH study investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02151643
GR  - MR/R005699/1/MRC_/Medical Research Council/United Kingdom
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Nephrol Dial Transplant
JT  - Nephrology, dialysis, transplantation : official publication of the European 
      Dialysis and Transplant Association - European Renal Association
JID - 8706402
RN  - 0 (Phosphates)
RN  - E1UOL152H7 (Iron)
SB  - IM
MH  - Double-Blind Method
MH  - Humans
MH  - *Hyperphosphatemia/drug therapy/etiology
MH  - Iron
MH  - Phosphates
MH  - Renal Dialysis
MH  - *Renal Insufficiency, Chronic/complications/therapy
PMC - PMC8311578
OTO - NOTNLM
OT  - PT20
OT  - chronic kidney disease
OT  - ferric oxide
OT  - hyperphosphataemia
OT  - phosphate binder
EDAT- 2020/07/12 06:00
MHDA- 2021/11/26 06:00
PMCR- 2020/07/11
CRDT- 2020/07/12 06:00
PHST- 2019/07/25 00:00 [received]
PHST- 2020/07/12 06:00 [pubmed]
PHST- 2021/11/26 06:00 [medline]
PHST- 2020/07/12 06:00 [entrez]
PHST- 2020/07/11 00:00 [pmc-release]
AID - 5870136 [pii]
AID - gfaa116 [pii]
AID - 10.1093/ndt/gfaa116 [doi]
PST - ppublish
SO  - Nephrol Dial Transplant. 2021 Jul 23;36(8):1399-1407. doi: 10.1093/ndt/gfaa116.