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

Hyperkalemia Clinical Trial

— HKRegistrypilo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466969
• Other study ID #: D9480R00030
• Status: Completed
• Start date: July 31, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2021
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Japan	Research Site	Iizukashi	Fukuoka
Japan	Research Site	Matsudoshi	Chiba
Japan	Research Site	Nagoyashi	Aichi
Japan	Research Site	Sashimagun	Ibaraki
Japan	Research Site	Tsuchiurashi	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analyse descriptive statistics of PROs	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.	4weeks

External Links

•   CSR Synopsis