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OpenTrials
Completed

NCT Number: NCT04466969

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

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:

  • EF ≤40%
  • 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

Treatment and study plan

Primary outcomes

  1. Analyse descriptive statistics of PROs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Acronym: HKRegistrypilo

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 10, 2020
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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