Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders, Sodium Polystyrene Sulphonate (SPS) or Calcium Polystyrene Sulphonate (CPS), Sodium Zirconium Cyclosilicate (Lokelma®), and Calcium Patiromer Sorbitex (Veltassa®) in Patients with Chronic Kidney Disease and Hyperkalaemia (APPETIZE)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49737
• EU PAS number:
  EUPAS36248
• Study ID:
  49737
• Official title and acronym:
  Non-Interventional, Exploratory, Phase IV, Single-Blind, Cross-Sectional, Randomised, Cross-over Study Evaluating Patient Palatability and Preference of 3 Potassium Binders, Sodium Polystyrene Sulphonate (SPS) or Calcium Polystyrene Sulphonate (CPS), Sodium Zirconium Cyclosilicate (Lokelma®), and Calcium Patiromer Sorbitex (Veltassa®) in Patients with Chronic Kidney Disease and Hyperkalaemia (APPETIZE)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Italy

  Spain

  United States
• Study description:
  Sodium zirconium cyclosilicate (hereafter referred to as Lokelma) has been approved in adults for effective and safe treatment of hyperkalaemia (HK), a metabolic condition characterised by elevated serum potassium (K+) levels above the normal range of 3.5–5.0 mmol/L. Patients with chronic kidney disease (CKD), diabetes, and those prescribed renin angiotensin aldosterone system inhibitor (RAASi) therapy are at an increased risk of HK due to abnormal K+ homeostasis, mainly due to impaired renal excretion. Sodium polystyrene sulphonate (SPS) or calcium polystyrene sulphonate (CPS) (hereafter referred to as S/CPS) are traditional K+ binders which are commonly prescribed but are poorly tolerated by patients due to lack of palatability and gastrointestinal (GI) constipation, leading to low adherence. Additionally, S/CPS use has been associated with serious GI adverse events (AEs, bleeding, ischemic colitis, colonic necrosis, colon perforation). Recently approved novel K+ binders, such as sodium zirconium cyclosilicate (Lokelma) and calcium patiromer sorbitex (hereafter referred to as Veltassa), are anecdotally reported to be more palatable and better tolerated in comparison to S/CPS, and provide additional treatment options to fulfil the unmet need for treatment of HK. There is a need to generate evidence for patients and physicians (nephrologists and cardiologists) on patient palatability and patient preference for currently available K+ binders and how preference could impact the likelihood of adherence and enable long-term HK pharmacological treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 32 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 29/05/2020

Actual: 25/03/2020

Study start date

Planned: 31/08/2020

Actual: 23/10/2020

Data analysis start date

Planned: 03/03/2022

Actual: 03/03/2022

Date of final study report

Planned: 16/09/2022

Actual: 21/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca AB

Study protocol

Initial protocol

D9480c00016_Study Protocol_V2.0_FINAL_02 June 2020 with signature

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable