Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-01 @ 5:59 PM
Study NCT ID:
NCT06884267
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperkalemia Quality Improvement Program (HK-QIP) Study
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HK-QIP
Brief 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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: