HyperkalemiaHK-QIPNCT06884267
Hyperkalemia Quality Improvement Program (HK-QIP) Study
A study testing standard hyperkalemia management implementation in people with Hyperkalemia, run by AstraZeneca at 49 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- standard hyperkalemia management implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 49 sitesChina
- Study dates
- 25 Jun 2025to 11 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, at the time of signing the informed consent.
- HK (sK+ > 5.0 mmol/L) within 48 hours before enrolment.
- 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.
- 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.
Who cannot join
- Patients on dialysis.
- 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.
- Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
- Patients with cardiac arrhythmias that require immediate treatment
- Patients scheduled for renal transplant or with a history of renal transplant.
- Life expectancy < 48 weeks.
Show all 12Show fewer
- 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.
- Be participating in other intervention clinical trials.
- 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.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
China49 sites
Research Site
Beijing, 100029
Research Site
Benxi, 117000
Research Site
Changchun, 130041
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Changsha, 410300
Research Site
Chengdu, 610031
Research Site
Chengdu, 610041
Research Site
Chengdu, 610078
Research Site
Chongqing, 400042
Research Site
Dalian, 116023
Research Site
Fuyang, 236600
Research Site
Fuzhou, 350005
Research Site
Fuzhou, 350031
Research Site
Gejiu, 661099
Research Site
Guangzhou, 510280
Research Site
Guangzhou, 510530
Research Site
Guiyang, 510630
Research Site
Haikou, 570311
Research Site
Hangzhou, 310006
Research Site
Hefei, 230001
Research Site
Hohhot, 10050
Research Site
Jinan, 250012
Research Site
Jinan, 250021
Research Site
Kunming, 650021
Research Site
Kunming, 650101
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330006
Research Site
Nanning, 530021
Research Site
Nantong, 226001
Research Site
Ningbo, 315010
Research Site
Pingdingshan, 467000
Research Site
Qiqihar, 161000
Research Site
Shanghai, 200025
Research Site
Shanghai, 200032
Research Site
Shanghai, 200233
Research Site
Shenyang, 110001
Research Site
Shijiazhuang, 50051
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300192
Research Site
Ürümqi, 830054
Research Site
Wuhan, 430022
Research Site
Wuhu, 241000
Research Site
Wuxi, 214062
Research Site
Xi'an, 710061
Research Site
Xining, 810001
Research Site
Xinxiang, 453100
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450003
About this study
Official title: A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
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.
Read the detailed description
This is a multi-center, prospective, single-arm interventional study to evaluate the impact on the implementation of standardized hyperkalemia management in CKD patients. Essentially, this is a quality improvement study to determine whether quality improvement intervention can improve medical care process and clinical outcomes.
The intervention of this study is standard hyperkalemia management implementation.
Intervention methods include standard disease management and quality audit.
- Key contents of HK disease management will be standard clinical pathway for management of HK disease based on GDMT (including sK+ > 5.0mmol/L as diagnose criteria; HK long term management; RAASi targeted dose treatment and sK+ test at least once/ 3 months and high-risk patients# once/month). Also track sK+ test frequency and RAASi optimization. Quality audit results as feedback for additional medical education. Medical trainings act as ways to educate HK disease management on both HCPs and patients' level. Education for HCPs include GDMT training*5 times at both study level and individual site level, added at individual site level if quality audit off target (added ≤ 1 time/site quarterly during 0-48 weeks after the first patient enrolled at this site, totally added ≤ 6 times/site). Education for patients include onsite training*6 times during 0-96 weeks and patient self-learning. (# High risk HK patients: CKD with DKD; CKD with HF; CKD with RAASi initiation or up titration.)
- Quality audit includes tracking HCP's perception and action of standardized HK management (quarterly from the first patient enrolled at this site) and patient's adherence to medication and sK+ monitoring (remote visit every 4 weeks [Q4W] and review patient daily checklist every 12 weeks [Q12W]).
- Patient enrolment will begin after the comprehensive GDMT training (both study level and individual site level) for HCPs. Approximately 1,000 adult Chinese patients with renal insufficiency and hyperkalemia will be enrolled from around 50 sites in China. Enrolled patients will be provided with treatment choice and HK management plan determined by HCPs, such as disease education, self management materials, prescription of RAASi use, sK+ test or potassium lowering therapy, etc.
- The follow-up duration will be up to 96 weeks. There will be 6 onsite visits for each patient after baseline visit and data collection, arranged on week 12, week 24, week 36, week 48, week 72 and week 96 after enrolment. Patients who withdraw/discontinue early from the study will have an "early withdrawl" visit.
- There will be remote visit for patients every 4 weeks if no onsite visit after enrolment.
- Conditions
- Hyperkalemia
- Being tested
- standard hyperkalemia management implementation
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard hyperkalemia management implementationOther
The interventions include HK disease management and quality audits for health care professionals (HCPs) and patients (Figure 1). The main contents of HK disease management in CKD include a standardized clinical pathway based on guideline adoption and medical trainings to educate HCPs and patients.
| Study group | Role | What they receive |
|---|---|---|
| one arm without control group | Other | This is a single-arm interventional study.This study will enroll 1,000 adult Chinese patients with non-dialysis chronic kidney disease (CKD-ND) and HK from around 50 sites in China. Receives: Other: standard hyperkalemia management implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve RAASi optimizationa with normal sK+ level (3.5 mmol/L ≤ sK+ ≤5.0 mmol/L) after 48 weeks intervention.
To describe the effectiveness of standardized management in patients with CKD and HK for achievement of sK+ control and RAASi optimization
Measured: Week 48
Secondary outcomes (3)
The proportion of patients with normal sK+ level 3.5 mmol/L≤ sK+ ≤ 5.0 mmol/L at each onsite visit.
To describe the effectiveness of HK standardized management in patients with CKD and HK for achievement of sK+ control
Measured: Week12，Week24，Week36，Week48，Week72，Week96
The proportion of patients who achieve RAASi optimization with normal sK+ level (3.5 mmol/L ≤ sK+ ≤ 5.0 mmol/L) after 12 weeks and 24 weeks intervention.
To describe the effectiveness of HK standardized management in patients with CKD and HK for achievement of sK+ control and RAASi optimization during follow up
Measured: Week12，Week24
Percentage change in UACR from baseline to week 48 and week 96 in patients with RAASi use at baseline.
To describe the improvement of urinary albumin after implementation of HK standardized management in patients with CKD and HK
Measured: Week48，Week96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start25 Jun 2025
- Primary completion11 Dec 2027 (estimated)
- Study completion11 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaoqiang Ding, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884267
- Sponsor's protocol ID
- D9480L00029
- Acronym
- HK-QIP
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Xie Y, Li Y, Wang Y, Lin J, Nie Y, Jiang W, Song N, Zhao S, Shen Z, Li Q, Zhang X, Ding X. Study protocol for a prospective, multicenter, single-arm study investigating the impact of the implementation of standardized hyperkalemia management in chronic kidney disease patients. BMC Nephrol. 2026 Apr 21;27(1):354. doi: 10.1186/s12882-026-04801-8.
PubMed 42015032
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06884267
- Acronym / sponsor ID
- HK-QIP / D9480L00029
- Conditions
- Hyperkalemia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 11 Dec 2027 (estimated)
- Study completion
- 11 Dec 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, prospective, single-arm interventional study to evaluate the impact on the implementation of standardized hyperkalemia management in CKD patients. Essentially, this is a quality improvement study to determine whether quality improvement intervention can improve medical care process and clinical outcomes.
The intervention of this study is standard hyperkalemia management implementation.
Intervention methods include standard disease management and quality audit.
- Key contents of HK disease management will be standard clinical pathway for management of HK disease based on GDMT (including sK+ > 5.0mmol/L as diagnose criteria; HK long term management; RAASi targeted dose treatment and sK+ test at least once/ 3 months and high-risk patients# once/month). Also track sK+ test frequency and RAASi optimization. Quality audit results as feedback for additional medical education. Medical trainings act as ways to educate HK disease management on both HCPs and patients' level. Education for HCPs include GDMT training*5 times at both study level and individual site level, added at individual site level if quality audit off target (added ≤ 1 time/site quarterly during 0-48 weeks after the first patient enrolled at this site, totally added ≤ 6 times/site). Education for patients include onsite training*6 times during 0-96 weeks and patient self-learning. (# High risk HK patients: CKD with DKD; CKD with HF; CKD with RAASi initiation or up titration.)
- Quality audit includes tracking HCP's perception and action of standardized HK management (quarterly from the first patient enrolled at this site) and patient's adherence to medication and sK+ monitoring (remote visit every 4 weeks [Q4W] and review patient daily checklist every 12 weeks [Q12W]).
- Patient enrolment will begin after the comprehensive GDMT training (both study level and individual site level) for HCPs. Approximately 1,000 adult Chinese patients with renal insufficiency and hyperkalemia will be enrolled from around 50 sites in China. Enrolled patients will be provided with treatment choice and HK management plan determined by HCPs, such as disease education, self management materials, prescription of RAASi use, sK+ test or potassium lowering therapy, etc.
- The follow-up duration will be up to 96 weeks. There will be 6 onsite visits for each patient after baseline visit and data collection, arranged on week 12, week 24, week 36, week 48, week 72 and week 96 after enrolment. Patients who withdraw/discontinue early from the study will have an "early withdrawl" visit.
- There will be remote visit for patients every 4 weeks if no onsite visit after enrolment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm without control group | Other | Other: standard hyperkalemia management implementationThis is a single-arm interventional study.This study will enroll 1,000 adult Chinese patients with non-dialysis chronic kidney disease (CKD-ND) and HK from around 50 sites in China. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years, at the time of signing the informed consent.
- HK (sK+ > 5.0 mmol/L) within 48 hours before enrolment.
- 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.
- 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.
Key exclusion criteria (12 listed)
- Patients on dialysis.
- 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.
- Patients with acute kidney injury (AKI) or diabetic ketoacidosis (DKA).
- Patients with cardiac arrhythmias that require immediate treatment
- Patients scheduled for renal transplant or with a history of renal transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard hyperkalemia management implementationThe interventions include HK disease management and quality audits for health care professionals (HCPs) and patients (Figure 1). The main contents of HK disease management in CKD include a standardized clinical pathway based on guideline adoption and medical trainings to educate HCPs and patients. | Other | one arm without control group |
Primary outcome
The proportion of patients who achieve RAASi optimizationa with normal sK+ level (3.5 mmol/L ≤ sK+ ≤5.0 mmol/L) after 48 weeks intervention.
Time frame: Week 48
To describe the effectiveness of standardized management in patients with CKD and HK for achievement of sK+ control and RAASi optimization
3 secondary outcomes
The proportion of patients with normal sK+ level 3.5 mmol/L≤ sK+ ≤ 5.0 mmol/L at each onsite visit.
Time frame: Week12，Week24，Week36，Week48，Week72，Week96
The proportion of patients who achieve RAASi optimization with normal sK+ level (3.5 mmol/L ≤ sK+ ≤ 5.0 mmol/L) after 12 weeks and 24 weeks intervention.
Time frame: Week12，Week24
Percentage change in UACR from baseline to week 48 and week 96 in patients with RAASi use at baseline.
Time frame: Week48，Week96
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42015032Xie Y, Li Y, Wang Y, Lin J, Nie Y, Jiang W, Song N, Zhao S, Shen Z, Li Q, Zhang X, Ding X. Study protocol for a prospective, multicenter, single-arm study investigating the impact of the implementation of standardized hyperkalemia management in chronic kidney disease patients. BMC Nephrol. 2026 Apr 21;27(1):354. doi: 10.1186/s12882-026-04801-8.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Hyperkalemia
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A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
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Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
Hyperkalemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoqiang Ding principal investigator
Fudan University
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard hyperkalemia management implementation in people with Hyperkalemia, run by AstraZeneca at 49 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who achieve RAASi optimizationa with normal sK+ level (3.5 mmol/L ≤ sK+ ≤5.0 mmol/L) after 48 weeks intervention. (time frame: Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.