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Hyperkalemia Quality Improvement Program (HK-QIP) Study

Active Not RecruitingNA

Sponsor: AstraZeneca

Conditions: Hyperkalemia

Interventions: standard hyperkalemia management implementation

Countries: China

This is a prospective, multi-center, single-arm study to evaluate the impact of implementation of guideline determined medical therapy (GDMT) for quality control improvement in non-dialysis chronic kidney disease (CKD-ND) patients, as well as provide evidence for standard hyperkalemia management with RAASi optimization in China CKD-ND patients.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years, at the time of signing the informed consent.
2. HK (sK+ \> 5.0 mmol/L) within 48 hours before enrolment.
3. Patients diagnosed as chronic kidney disease with eGFR\>10 ml/min/1.73m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021). See 8.3.4 for detailed equation.
4. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion Criteria:

1. Patients on dialysis.
2. Pseudohyperkalemia signs and symptoms, such as hemolyzed blood specimen due to excessive fist clenching to make veins prominent, difficult or traumatic venipuncture, or history of severe leukocytosis or thrombocytosis.
3. Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
4. Patients with cardiac arrhythmias that require immediate treatment
5. Patients scheduled for renal transplant or with a history of renal transplant.
6. Life expectancy \< 48 weeks.
7. History of malignancy except for:

7.1 Malignancy treated with curative intent and with no known active disease within 3 years before the enrolment and of low potential risk for recurrence.

7.2 Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.

7.3 Adequately treated carcinoma in situ without evidence of disease.
8. Be participating in other intervention clinical trials.
9. Judgment by the HCP that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Locations (49)

Beijing, China
Benxi, China
Changchun, China
Changsha, China
Changsha, China
Changsha, China
Chengdu, China
Chengdu, China
Chengdu, China
Chongqing, China
Dalian, China
Fuyang, China
Fuzhou, China
Fuzhou, China
Gejiu, China
Guangzhou, China
Guangzhou, China
Guiyang, China
Haikou, China
Hangzhou, China
Hefei, China
Hohhot, China
Jinan, China
Jinan, China
Kunming, China
Kunming, China
Lanzhou, China
Nanchang, China
Nanning, China
Nantong, China
+ 19 more on CT.gov