REALIZE-K

• Research type

  Research Study

• Full title

  Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone (REALIZE-K)

• IRAS ID

  290502

• Contact name

  Iain Squire

• Contact email

  is11@le.ac.uk

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2020-003312-27

• Clinicaltrials.gov Identifier

  NCT04676646

• Duration of Study in the UK

  0 years, 10 months, 2 days

• Research summary

  The primary objective of this study is to evaluate the efficacy of Sodium zirconium cyclosilicate (SZC) as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK). Approximately 400 patients may take part in this study from approximately 50 sites globally.

  This is a parallel-group, placebo-controlled, multi-centre study with an open-label run-in phase.
  The population studied will be patients with symptomatic Heart Failure with Reduced Ejection Fraction who are taking no spironolactone or eplerenone or low-dose spironolactone (<25 mg daily) at screening.
  Patients who are Normokalaemic on SZC and receiving spironolactone ≥25 mg daily at the end of the open-label run-in phase will be randomised to SZC or placebo during the double-blind phase with randomisation stratified according to the presence of HK/NK at study entry.

  Total duration of study participation for each patient will be approximately 10 months, including 9 months on treatment. The study consists of 3 periods:

  1. Screening period (2 weeks)
  2. Treatment period (9 months)
  a. Open-label, run-in phase (4-6 weeks)
  i. Cohort 1 (4 weeks): Patients who are HK at study entry
  ii. Cohort 2 (4-6 weeks): Patients who are NK at study entry

  Note: Patients in Cohort 2 who do not develop HK during the first 3 weeks will be discontinued from the study during the run-in phase.

  b. Double-blind, placebo-controlled, randomised-withdrawal phase (8 months): Patients who are NK on SZC and receiving spironolactone ≥25 mg daily at the end of the run-in phase will be randomised 1:1 to SZC or placebo stratified according to the presence of HK/NK (open label Cohort 1 vs. Cohort 2) at study entry, continuing on the dose they were being administered at the end of the run-in phase.

  3. Follow-up period (3 weeks) after the EOT visit

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0028

• Date of REC Opinion

  25 Mar 2021

• REC opinion

  Further Information Favourable Opinion