The approval by the NMPA was primarily based on information from the Part IIIb DIALIZE trial, the primary ever randomised, placebo-controlled trial to guage a potassium binder in sufferers on steady haemodialysis. The trial confirmed sustained potassium management pre-dialysis for extra sufferers receiving Lokelma, in contrast with placebo.1
Lokelma was authorized for the remedy of grownup sufferers with hyperkalaemia in
In DIALIZE, 41% of sufferers receiving Lokelma maintained pre-dialysis potassium ranges on at the very least three out of 4 dialysis remedies after the lengthy interdialytic interval and didn’t require pressing rescue remedy. This in contrast with 1% of sufferers receiving placebo, making it a statistically important and clinically significant enchancment (p5.5 mmol/L.Eight Sufferers with excessive variability in potassium ranges between dialysis periods are at important danger of arrhythmias, which may result in cardiac arrest.Four Worldwide, there are an estimated 700 million and 64 million individuals residing with CKD and HF respectively with hyperkalaemia occurring in 23 to 47% of sufferers with superior CKD (stage 3-4) and/or HF.9-11
DIALIZE is the primary ever randomised, placebo-controlled trial to guage a potassium binder in sufferers on steady haemodialysis. The Part IIIb, multicentre, double-blinded trial investigated the efficacy and security of Lokelma versus placebo in 196 sufferers on haemodialysis with hyperkalaemia. Sufferers had been randomised to obtain Lokelma or placebo as soon as each day on non-dialysis days for a remedy interval of eight weeks. This included a four-week dose adjustment part (beginning at 5g and titrated weekly in 5g increments as much as a most of 15g) and a four-week analysis part on steady dose.
The complete outcomes of the DIALIZE trial had been revealed in
Lokelma (sodium zirconium cyclosilicate) is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, that acts as a extremely selective potassium-removing drugs. It’s administered orally, is odourless, tasteless and steady at room temperature.12.13 It has been studied in three double-blinded, placebo-controlled trials and in a single 12-month open label scientific trial in sufferers with hyperkalaemia.
Cardiovascular, Renal and Metabolism (CVRM) collectively types one in every of
For particulars on the right way to contact the Investor Relations Workforce, please click on right here. For Media contacts, click on right here.
1, Fishbane S et al. A Part 3b, Randomized, Double-Blind, Placebo-Managed Examine of Sodium Zirconium Cyclosilicate for Decreasing the Incidence of Predialysis Hyperkalemia. J Am Soc Nephrol 2019.
2. Wang F et al. Govt abstract for the 2015 Annual Information Report of the China Kidney Illness Community (CK-NET).
3. Kovesdy CP. Administration of hyperkalaemia in power kidney illness. Nat Rev Nephrol.
4. Kovesdy CP. et al. Serum and Dialysate Potassium Concentrations and Survival in Hemodialysis Sufferers. Clin J Am Soc Nephrol. 2007:2:999-1007.
5. Evans KJ, Greenberg A. Hyperkalemia: A overview. J Intensive Care Med. 2005;20:272-290.
6. Kramer A et al.
7. United States Renal Information System. 2018 Annual Information Report Quantity 2:
8. Xu H et al. Prevalence of hyperkalemia in DOPPS: An actual-world, worldwide cohort of hemodialysis sufferers (MP371). introduced at: ERA-EDTA Annual Congress 2017, 2019
9. Vos T et al. International, regional, and nationwide incidence, prevalence, and years lived with incapacity for 328 illnesses and accidents for 195 nations, 1990-2016: A scientific evaluation for the International Burden of Illness Examine 2016. The Lancet2017; 390(10100):1211-59.
10. James SL et al. International, regional, and nationwide incidence, prevalence, and years lived with incapacity for 354 illnesses and accidents for 195 nations and territories, 1990-2017: A scientific evaluation for the International Burden of Illness Examine 2017. The
11. Latts LM et al. Hyperkalemia Is Prevalent in Sufferers with Cardiorenal Comorbidities. introduced at: ISPOR 20th Annual Worldwide Assembly, 2015 May 16 – 20,
12. LOKELMA® (sodium zirconium cyclosilicate) US Prescribing Info; final replace:
13. Kosiborod M et al. Impact of sodium zirconium cyclosilicate on potassium decreasing for 28 days amongst outpatients with hyperkalemia: The HARMONIZE randomized scientific trial. JAMA 2014; 312(21):2223-33.
Approval ID: Z4-29004 | Date of Preparation: