Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04466969
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Hyperkalemia

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Assessment of Hyperkalemia`s Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study
Estimated Study Start Date : July 31, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04466969    
Other Study ID Numbers: D9480R00030
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Heart Failure
Hyperkalemia
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Water-Electrolyte Imbalance
Metabolic Diseases