Phase
Condition
Kidney Failure
Kidney Disease
Nephropathy
Treatment
Local standard of care
Sodium Zirconium Cyclosilicate (SZC)
Clinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Must be 18 years of age or older, at the time of signing the informed consent
Admitted to hospital (inpatient care; directly or from ED)
With:
Diagnosed CKD (any stage) or
eGFR < 90 ml/min/1.73 m2 at, or within 3 months of, study screening, based onthe Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Leveyet al, 2009).
Note: Race/ethnicity should not be included in CKD-EPI equation calculation.
Local laboratory K+ measurement within 24 hours of baseline visit (visit 2), whereresult is either:
Hyperkalaemic as defined by site's local practice and K+ ≤ 6.5 mmol/L.
Or, normokalaemic: K+ between ≥ 3.5 and ≤ 5.0 mmol/L, where patient started and isreceiving treatment for this episode of HK
Male or female
Capable and willing of giving signed informed consent as described in Appendix Awhich includes compliance with the requirements and restrictions listed in theinformed consent form (ICF) and in this protocol.
Exclusion
Exclusion Criteria:
Hospitalisation for an acute cardiovascular event within 12 weeks prior to screening
Unable to take oral SZC drug mix
With a life expectancy of less than 6 months
Any medical condition that, in the opinion of the investigator makes the participantnot suitable for inclusion
QT interval corrected by the Fridericia method (QTcF) > 550 msec
History of QT prolongation associated with other medications that requireddiscontinuation of that medication
Congenital long QT syndrome
Clinically significant arrythmias as judged by the investigator
Ongoing treatment with SZC or patiromer before current ED visit/hospital admission (ongoing treatment with other K-binders before current ED visit/hospital admissionis allowed).
Note: Initiation of any SZC or patiromer during the current ED visit/hospitalisation preceding enrolment is allowed.
Chronic haemodialysis or peritoneal dialysis or the recipient of or scheduled datefor a kidney transplant. Note: Emergency/unscheduled haemodialysis to treat HKduring the current ED visit/hospitalisation preceding enrolment is allowed.
Participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening.
Known hypersensitivity to SZC or any of the excipients of the product
Involvement in the planning and/or conduct of the study (applies to both AstraZenecastaff and/or staff at the study site)
Judgment by the investigator that the participant should not participate in thestudy if the participant is unlikely to comply with study procedures, restrictions,and requirements
Previous randomisation in the present study
For women only: Women of child-bearing potential (WOCBP; ie, those who are notchemically or surgically sterilised or who are not post-menopausal) who are notwilling to use one of the methods of contraception described hereafter, or who arenot stable on the contraception method for the last one month, from the time ofsigning the informed consent throughout the study and 7 days after the last dose: (a) Combined (estrogen and progestogen containing) hormonal contraception associatedwith inhibition of ovulation: oral, intravaginal, transdermal (b) Progestogen-onlyhormonal contraception associated with inhibition of ovulation: oral, injectable,implantable (c) Intrauterine device (d) Intrauterine hormone-releasing system (e)Bilateral tubal occlusion (f) Vasectomised partner (vasectomised partner is a highlyeffective birth control method provided that partner is the sole sexual partner ofthe WOCBP participant and that the vasectomised partner has received medicalassessment of the surgical success (g) Sexual abstinence: it is considered a highlyeffective method only if defined as refraining from heterosexual intercourse duringthe entire period of risk associated with the study treatments. The reliability ofsexual abstinence needs to be evaluated in relation to the duration of the study andthe preferred and usual lifestyle of the participant.
For WOCBP only: Women who have a positive pregnancy test at screening OR women whoare breastfeeding.
Study Design
Study Description
Connect with a study center
Research Site
Belgium, 1200
BelgiumSite Not Available
Research Site
Bonheiden, 2820
BelgiumSite Not Available
Research Site
Dendermonde, 9200
BelgiumSite Not Available
Research Site
Leuven, 3000
BelgiumSite Not Available
Research Site
Lodelinsart, 6042
BelgiumSite Not Available
Research Site
Annonay, 07103
FranceSite Not Available
Research Site
Ars-Laquenexy, 57530
FranceSite Not Available
Research Site
La Tronche, 38043
FranceSite Not Available
Research Site
Nice, 06000
FranceSite Not Available
Research Site
Saint-priest En Jarez, 42270
FranceSite Not Available
Research Site
Kaiserslautern, 67655
GermanySite Not Available
Research Site
Acireale, 95024
ItalySite Not Available
Research Site
Bari, 70120
ItalySite Not Available
Research Site
Foggia, 71122
ItalySite Not Available
Research Site
Parma, 43125
ItalySite Not Available
Research Site
Pavia, 27100
ItalySite Not Available
Research Site
Roma, 00163
ItalySite Not Available
Research Site
Amsterdam, 1105AZ
NetherlandsSite Not Available
Research Site
Eindhoven, 5602 ZA
NetherlandsSite Not Available
Research Site
Groningen, 9700 RB
NetherlandsSite Not Available
Research Site
Rotterdam, 3015 CE
NetherlandsSite Not Available
Research Site
Alcalá De Henares, 28805
SpainSite Not Available
Research Site
Algeciras, 11207
SpainSite Not Available
Research Site
Alicante, 03010
SpainSite Not Available
Research Site
Almería, 04009
SpainSite Not Available
Research Site
Badajoz, 06080
SpainSite Not Available
Research Site
Barcelona, 08907
SpainSite Not Available
Research Site
Burgos, 9006
SpainSite Not Available
Research Site
Getafe, 28905
SpainSite Not Available
Research Site
Madrid, 28040
SpainSite Not Available
Research Site
Palma de Mallorca, 7120
SpainSite Not Available
Research Site
Salamanca, 37007
SpainSite Not Available
Research Site
San Sebastián de los Reyes, 28702
SpainSite Not Available
Research Site
Santiago de Compostela, 15706
SpainSite Not Available
Research Site
Sevilla, 41009
SpainSite Not Available
Research Site
Talavera de la Reina, 45600
SpainSite Not Available
Research Site
Zamora, 49022
SpainSite Not Available
Research Site
Cardiff, CF14 4XW
United KingdomSite Not Available
Research Site
Doncaster, DN2 5LT
United KingdomSite Not Available
Research Site
Edinburgh, EH16 4SA
United KingdomSite Not Available
Research Site
Hull, HU10 7AZ
United KingdomSite Not Available
Research Site
Leicester, LE5 4PW
United KingdomSite Not Available
Research Site
London, 6BQ
United KingdomSite Not Available
Research Site
Salford, M6 8HD
United KingdomSite Not Available
Research Site
Stevenage, SG1 4AB
United KingdomSite Not Available
Research Site
York, YO31 8HE
United KingdomSite Not Available
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