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

NCT04466969 | Completed

• 1 other identifier: D9480R00030
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

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

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

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

stages of CKD (stage 5)

CKD is diagnosed based on the following eGFR categories: eGFR \<15 mL/min/1.73m2

Treated by potassium binders

Patients who have been treated by Potassium Binders

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include patients with hyperkalemia treated at outpatient clinics. Eligible patients will be screened through the regular visit to study sites in a consecutive manner. This study will be conducted in outpatient clinics in general hospitals. 150 hyperkalemia patients with CKD or HFrEF will be enrolled and assessed cross-sectionally. After the written informed consent, subjects will be asked to complete the questionnaire-based survey. Health-Related Quality of Life (HR-QoL), compliance to treatment with potassium binders, and other factors including age, sex, height, weight, smoking status, alcohol use and socio-economic status will be collected through the designated questionnaires. Information on disease status and on treatment patterns will be collected from physicians, and the latest results of laboratory tests will be collected from medical records (within 6 months before enrolment).

You may qualify if:

• Outpatients aged ≥20 years
• Hyperkalemia patients defined as meeting either of the following criteria:
• Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment
• Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment
• 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
• 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.
• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Nagoya, Aichi-ken, 457-8511, Japan

Location

Research Site

Matsudoshi, Chiba, 271-0077, Japan

Location

Research Site

Iizukashi, Fukuoka, 820-8505, Japan

Location

Research Site

Sashimagun, Ibaraki, 306-0433, Japan

Location

Research Site

Tsuchiurashi, Ibaraki, 300-0028, Japan

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Hyperkalemia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: July 31, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

JP (5)