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

NCT ID: NCT04466969

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 146 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2020-11-30

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

Conditions

Hyperkalemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

HF

Patients with HF with reduced Ejection Fraction (HFrEF) is enrolled if patients meet following criteria within 6 months:

1. Ejection Fraction ratio（EF） ≤40%

2. New York Heart Association(NYHA) class II-IV

No interventions assigned to this group

stages of CKD (stage 3b)

CKD is diagnosed based on the following e Glomerular Filtration Rate (eGFR) categories:

Stage 3b: 30 mL/min/1.73m2 ≤ eGFR <45 mL/min/1.73m2

No interventions assigned to this group

Stages of CKD (stage 4)

CKD is diagnosed based on the following eGFR categories:

15 mL/min/1.73m2 ≤ eGFR <30 mL/min/1.73m2

No interventions assigned to this group

stages of CKD (stage 5)

CKD is diagnosed based on the following eGFR categories:

eGFR <15 mL/min/1.73m2

No interventions assigned to this group

Treated by potassium binders

Patients who have been treated by Potassium Binders

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Nagoya, Aichi-ken, Japan

Research Site

Matsudoshi, Chiba, Japan

Research Site

Iizukashi, Fukuoka, Japan

Research Site

Sashimagun, Ibaraki, Japan

Research Site

Tsuchiurashi, Ibaraki, Japan

Countries

Japan

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9480R00030&amp;attachmentIdentifier=ca791ad0-f043-4151-ac36-d7a3e8d6023b&amp;fileName=CSR_synopsis.pdf&amp;versionIdentifier=

CSR Synopsis

Other Identifiers

D9480R00030

Identifier Type: -

Identifier Source: org_study_id