Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study

Completed

• Conditions: Hyperkalemia

• Registration Number: NCT04466969
• Lead Sponsor: AstraZeneca

Brief Summary

Overall study aim of this study is to analyse descriptive statistics of Patient-Reported Outcome（PROs） which will be used in the Hyperkalemia（HK） registry study in hyperkalemia patients with Chronic Kidney Disease（CKD） or Heart Failure（HF） to describe the practice patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this study will provide the information for the applicability of PRO measurements which will be used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients with hyperkalemia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-10
• Study Start: 2020-07-31
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Outpatients aged ≥20 years

• Hyperkalemia patients defined as meeting either of the following criteria:

  1. Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
  2. Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
  3. Currently treated by potassium binders for the treatment of hyperkalemia at enrolment

• Having been diagnosed as CKD (≥stage 3b) or HFrEF by investigators as defined below:

CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for ≥3 months

1. Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy. Especially, existence of ≥0.15 g/gCr of proteinuria (≥30 mg/gCr of albuminuria) is important.
2. GFR <45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum creatinine, gender, and age using following the formulation.

eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for female patients, x 0.739)

≥Stage 3b CKD is diagnosed based on the following eGFR categories:

• Stage 3b: 30 mL/min/1.73m2 ≤ eGFR <45 mL/min/1.73m2
• Stage 4: 15 mL/min/1.73m2 ≤ eGFR <30 mL/min/1.73m2
• Stage 5: eGFR <15 mL/min/1.73m2

Patients with HFrEF is enrolled if patients meet following criteria within 6 months:

1. EF ≤40%

2. NYHA class II-IV

   • Provision of signed, written, and detailed informed consent
   • Signed written informed consent by themselves

Exclusion Criteria

• Currently on any chronic RRT (including hemodialysis or peritoneal dialysis >30 days, or kidney transplant) within 6 months before enrolment
• Patients with acute kidney injury at enrolment •Patients who took blood transfusion or potassium supplements within 6 months before enrolment
• Active malignancy or life expectancy of less than 6 months.
• Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine those affect significantly serum K level
• Patients who have autoimmune disorders, and investigators determine those affect significantly serum K level
• Patients whose lab data have suspicion for pseudohyperkalemia
• Patients who are pregnant, lactating, or planning to become pregnant
• Current participation in interventional studies and/or clinical trials
• Patients who, in the opinion of the investigators, would be unlikely to comply with self-assessments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analyse descriptive statistics of PROs	4weeks	The primary focus of this study is to analyse descriptive statistics of PROs which will be used in the Hyperkalemia registry. Information on demographics, medical history, treatment patterns, medication compliance, and self-reported questionnaire will be collected.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tsuchiurashi, Ibaraki, Japan