Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia

Launched by ASTRAZENECA · Jul 30, 2021

Keywords

ClinConnect Summary

This is a Phase IV, randomised, controlled, open-label, parallel-group, multicentre, prospective study to evaluate the effect of the combination of SZC and enhanced nutritional advice to consume fruit and vegetables as compared to SoC in reducing S-K+ levels in participants with hyperkalaemia on haemodialysis. Following 7-day screening, all participants who are enrolled will begin an up to 1-month HK Treatment Phase with SZC as per local label. Participants will receive dietary advice consistent with SoC at that site, including K+ restriction. A 4-month Diet Comparison Phase will begin next...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥18 years of age at the time of signing the informed consent.
• • 2. Participants with prevalent HK (S-K+ \>5.5 mmol/L at the end of LIDI) not requiring acute treatment.
• • 3. Receiving haemodialysis 3 times a week with stable vascular access for at least 3 months before screening visit.
• • 4. Participants who have and are able and willing to use smart phone (android or iOS) nutrition app.
• • 5. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• • Female participants of childbearing potential must have a negative pregnancy test.
• • Female participants must be 1 year post-menopausal, surgically sterile, or using 1 highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose.
• • 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
• Exclusion Criteria:
• • 1. As judged by the investigator or sponsor, any medical condition (including active, clinically significant infection) that may pose a safety risk to the participant in this study, may confound safety or efficacy assessments and jeopardise the quality of data, or may interfere with study participation.
• • 2. Myocardial infarction, acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina), stroke, seizure, thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft within 12 weeks prior to screening visit.
• • 3. Severe leucocytosis (\>20 × 109 /L) or thrombocytosis (≥450 × 109 /L) during screening.
• • 4. Polycythaemia (haemoglobin \>14 g/dL) during screening.
• • 5. Severe constipation, bowel obstruction, post-operative motility disorders.
• • 6. Scheduled date for living donor kidney transplant.
• • 7. Participants with a life expectancy of less than 6 months.
• • 8. Females of childbearing potential, unless using contraception as detailed in the protocol or sexually abstinent.
• • 9. Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
• • 10. Presence of cardiac arrhythmias or conduction defects that require immediate treatment at HCP discretion.
• • 11. History of alcohol or drug abuse within 2 years prior to screening visit.
• • 12. History of QT prolongation associated with other medications that required discontinuation of that medication.
• • 13. Congenital long QT syndrome or QT interval corrected for heart rate (QTc) using Fridericia's method (QTcF) \>550 ms.
• • 14. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
• • 15. If the participant has evidence of Coronavirus disease 2019 (COVID-19) within 2 weeks prior to screening (see Appendix D), the participant cannot be enrolled in the study.
• • 16. Participants treated with SZC, sodium polystyrene sulfonate (SPS: Kayexalate™; Resonium™ A), calcium polystyrene sulfonate (CPS: Calcium Resonium™), or patiromer (Veltassa™) 1 within 4 weeks before screening.
• • 17. Participants with a known hypersensitivity or previous anaphylaxis to SZC or any of the excipients of the product.
• • 18. Participants unable to take oral SZC. Prior/Concurrent Clinical Study Experience
• • 19. Participation in another clinical study with an investigational product administered during the month before screening2 .
• • 20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
• • 21. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• • 22. Previous enrolment in the present study.