A Prospective, Multicenter, Single Arm Study to Evaluate the Impact on the Implementation of Standardized Hyperkalemia Management in Chronic Kidney Disease Patients

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Research Site
RECRUITING
Shanghai
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-12-11
Participants
Target number of participants: 1000
Treatments
Other: one arm without control group
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.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov