Hyperkalaemia Clinical Trial
— SCRUTINIZEOfficial title:
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety of Oral Resin for Treatment of Hyperkalemia in Chinese Patients With Renal Insufficiency
Verified date | January 2024 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 887 |
Est. completion date | December 29, 2023 |
Est. primary completion date | December 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University People's Hospital | Beijing | Beijing |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of AEs | Number and percentage of AEs | From enrollment to the 6th month after enrollment | |
Primary | Occurrence of SAEs | Number and percentage of SAEs | From enrollment to the 6th month after enrollment | |
Primary | Occurrence of DAEs | Number and percentage of DAEs | From enrollment to the 6th month after enrollment | |
Secondary | Occurrence of AEs judged by the investigators to be causally related to CPS/SPS | Number and percentage of AEs judged by the investigators to be causally related to CPS/SPS | From enrollment to the 6th month after Enrollment | |
Secondary | Occurrence of SAEs judged by the investigators to be causally related to CPS/SPS | Number and percentage of SAEs judged by the investigators to be causally related to CPS/SPS | From enrollment to the 6th month after Enrollment | |
Secondary | Occurrence of DAEs judged by the investigators to be causally related to CPS/SPS | Number and percentage of DAEs judged by the investigators to be causally related to CPS/SPS | From enrollment to the 6th month after Enrollment | |
Secondary | Average CPS/SPS daily dosage | Average CPS/SPS daily dosage | From enrollment to the 6th month after enrollment | |
Secondary | Frequency of different CPS/SPS dosages | Frequency of different CPS/SPS dosages | From enrollment to the 6th month after enrollment | |
Secondary | Duration of CPS/SPS treatment | Duration of CPS/SPS treatment | From enrollment to the 6th month after enrollment | |
Secondary | CPS/SPS dose changes | CPS/SPS dose changes | From enrollment to the 6th month after enrollment | |
Secondary | Reasons for any CPS/SPS dose changes | Reasons for any CPS/SPS dose changes | From enrollment to the 6th month after enrollment | |
Secondary | Change in sK tested between V1 and V2 (patients in new user group), as well as average (within patient) sK levels | Change in sK tested between V1 and V2 (patients in new user group), as well as average (within patient) sK levels during the study. An evaluation of whether or not a patient tends to be normokalemic. Two criteria for normokalemia will be considered:
sK between 3.5 to 5.0 mmol/L, inclusive sK between 3.5 to 5.5 mmol/L, inclusive. |
From enrollment to the 6th month after enrollment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04676646 -
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
|
Phase 4 | |
Completed |
NCT04788641 -
Study to Assess the Effect of Sodium Zirconium Cyclosilicate on the Pharmacokinetics of Tacrolimus and Cyclosporin in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT05347693 -
Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study
|
Phase 4 | |
Completed |
NCT05271266 -
A Multicenter, Prospective, Non-interventional Cohort Study to Evaluate the Safety and Treatment Pattern of Sodium Zirconium Cyclosilicate for Hyperkalaemia Management in Real World Practice in China
|
||
Terminated |
NCT04727528 -
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
|
Phase 3 | |
Recruiting |
NCT04249648 -
Hyperkalaemia and Its Impact on Therapy With RAASi
|
||
Recruiting |
NCT06185660 -
A National, Multicenter, Prospective, Observational Study to Assess Patient Characteristics, Treatment Algorithms and Disease Management of Hyperkalaemia Patients With Chronic Kidney Disease or Under Dialysis or With Heart Failure, Treated With Sodium Zirconium Cyclosilicate in Greece
|
||
Terminated |
NCT04997161 -
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
|
Phase 4 | |
Recruiting |
NCT03813407 -
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
|
Phase 3 |