Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
SCRUTINIZE
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
1 other identifier
observational
887
1 country
16
Brief Summary
It is a multicenter, prospective, non-interventional cohort study, in order to evaluate the safety of oral resin for treatment of hyperkalemia in Chinese patients with renal insufficiency.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedStudy Start
First participant enrolled
August 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedDecember 3, 2024
November 1, 2024
1.4 years
May 23, 2022
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Occurrence of AEs
Number and percentage of AEs
From enrollment to the 6th month after enrollment
Occurrence of SAEs
Number and percentage of SAEs
From enrollment to the 6th month after enrollment
Occurrence of DAEs
Number and percentage of DAEs
From enrollment to the 6th month after enrollment
Secondary Outcomes (9)
Occurrence of AEs judged by the investigators to be causally related to CPS/SPS
From enrollment to the 6th month after Enrollment
Occurrence of SAEs judged by the investigators to be causally related to CPS/SPS
From enrollment to the 6th month after Enrollment
Occurrence of DAEs judged by the investigators to be causally related to CPS/SPS
From enrollment to the 6th month after Enrollment
Average CPS/SPS daily dosage
From enrollment to the 6th month after enrollment
Frequency of different CPS/SPS dosages
From enrollment to the 6th month after enrollment
- +4 more secondary outcomes
Eligibility Criteria
This study will enroll eligible Chinese patients who are new and ongoing users on CPS/SPS at Study Enrollment from approximately 30 sites in China recruiting 1000 patients. New users are defined that the patients without CPS/SPS treatment within 7 days before Study Enrollment Day takeCPS/SPS treatment on Study Enrollment Day. Ongoing users are defined that the patients with CPS/SPS treatment within 7 days before Study Enrollment Day continue CPS/SPS treatment after enrollment. The patients with previous CPS/SPS treatment who will not continue taking CPS/SPStreatment after enrollment will not be included. Eligible patients will be those who meet all inclusion criteria but not any exclusion criteria. Eligible patients can be patients with or without hemodialysis treatment.
You may qualify if:
- Age ≥ 18 year-old
- Provision of patient informed consent prior to any study procedure
- Patients diagnosed as CKD or AKI
- HK (sK+ \> 5.0 mmol/L) diagnosed by physicians within 1 year before Day 1
- Currently taking CPS/SPS, or have been prescribed and agree to start taking CPS/SPS since Day 1.
You may not qualify if:
- Being unable to comply with study-specified procedures
- Has ever participated in current study before, or participating in any interventional study at Day 1 or within the last 3 months before Day 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (16)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Research Site
Beijing, China
Research Site
Dalian, China
Research Site
Dongyang, China
Research Site
Hangzhou, China
Research Site
Hefei, China
Research Site
Jinan, China
Research Site
Kaifeng, China
Research Site
Ningbo, China
Research Site
Qingdao, China
Research Site
Shijiazhuang, China
Research Site
Tianjin, China
Research Site
Xuzhou, China
Research Site
Yangzhou, China
Research Site
Zhangjiagang, China
Research Site
Zhengzhou, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Zuo
Peking University People's Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2022
First Posted
July 18, 2022
Study Start
August 22, 2022
Primary Completion
December 29, 2023
Study Completion
December 29, 2023
Last Updated
December 3, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.