NCT07481526

Brief Summary

This is a prospective, multicenter, observational registry study designed to collect data to deepen the understanding of CKD therapeutics, changes in clinical practice, cardiorenal risk outcomes and differences in treatment approaches in Chinese CKD patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress8%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

February 13, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

February 27, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

February 13, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (31)

  • Proportion of CKD patients with HP, HF, HTN, and HK at baseline, respectively

    To determine the prevalence of HP, HF, HTN, and HK among patients with CKD

    baseline

  • Adoption rate of medications (e.g., Endothelin receptor antagonists [ERA], MRA, RASi, SGLT2i)

    To describe the treatment patterns in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of eGFR slope in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the clinical composite outcome of eGFR decline ≥50% for CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the clinical composite outcome of End-stage renal disease(ESRD) for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the clinical composite outcome of renal death for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the clinical composite outcome of CV death for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the renal outcome of ≥50% eGFR decline from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the renal outcome of ESRD from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the renal outcome of RRT(renal replacement therapy) from baseline for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the renal outcome of CKD stage progression for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the renal outcome of Renal-related death for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the CV outcome of MACE(major adverse cardiovascular events) for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the CV outcome of HF for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe the CV outcome of CV death (included in the composite of renal or CV death) for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe all-cause death for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP,HF,HTN,or HK

    To describe all-cause hospitalization for all CKD patients and subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients with HK

    To describe HK outcomes of HK recurrence for all CKD patients with HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients with HK

    To describe HK outcomes of Severe HK requiring hospitalisation for all CKD patients with HK.

    Week 0 to week 96

  • Clinical outcomes of CKD patients with HK

    To describe HK outcomes of Severe HK requiring emergency-department visits for all CKD patients with HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of change in eGFR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Change in UACR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Change in UPCR from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Change in UPER from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Proportion of patients achieving UACR \<700 mg/g with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Proportion of patients achieving UPCR \< 1000 mg/g and ≥ 30% reduction from baseline over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients and CKD patients with HP, HF, HTN, or HK

    To describe the clinical indicators of Proportion of patients achieving UPER \<1000 mg/24h with ≥30% reduction over time in patients with CKD overall, and in subgroups with HP, HF, HTN, or HK.

    Week 0 to week 96

  • Clinical indicators for CKD patients with HP and HTN

    To describe the clinical indicators of Change in systolic BP from baseline over time in patients with CKD and subgroups of HP and HTN.

    Week 0 to week 96

  • Clinical indicators for CKD patients with HP and HTN

    To describe the clinical indicators of Change in diastolic BP from baseline over time in patients with CKD and subgroups of HP and HTN.

    Week 0 to week 96

  • Clinical indicators for CKD patients with HP and HTN

    To describe the clinical indicators of Proportion of patients achieving BP control target over time in patients with CKD and subgroups of HP and HTN.

    Week 0 to week 96

  • Clinical indicators for CKD patients with HF

    To describe the clinical indicators of Change of NT-proBNP from baseline over time in patients with CKD with HF.

    Week 0 to week 96

Secondary Outcomes (60)

  • Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK

    Week 0 to week 96

  • The HCRU among patients with CKD overall, and in subgroups with HP, HF, HTN, or HK

    Week 0 to week 96

  • The factors associated with the clinical indicators in patients with CKD overall, and in subgroups

    Week 0 to week 96

  • Clinical outcomes of CKD patients and CKD patients with HP, HF, HTN, or HK

    Week 0 to week 96

  • Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK

    Week 0 to week 96

  • +55 more secondary outcomes

Other Outcomes (38)

  • Clinical indicators of CKD patients and CKD patients with HP, HF, HTN, or HK

    Week 0 to week 96

  • The HCRU among patients with CKD overall, and in subgroups

    Week 0 to week 96

  • The HCRU among patients with CKD overall, and in subgroups

    Week 0 to week 96

  • +35 more other outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult CKD patients who meet the eligibility criteria

You may qualify if:

  • Male or female patients aged ≥18 years.
  • Willing and able to provide written informed consent to participate in the study.
  • Confirmed CKD diagnosis at enrolment, defined by at least one of the following:
  • eGFR \<60 mL/min/1.73 m² for ≥3 months, OR
  • Evidence of kidney damage (e.g., UACR ≥30 mg/g or UPCR ≥150 mg/g, structural abnormality on imaging, or kidney biopsy findings consistent with chronic kidney injury) persisting for ≥3 months

You may not qualify if:

  • Having a life-threatening comorbidity with life expectancy \< 2 years.
  • Severe cardiac disease: life-threatening arrhythmias, or recent MACE (Myocardial infarction (MI), stroke, CV death) within the past 3 months.
  • Pregnant or breastfeeding women.
  • Currently enrolled in any interventional clinical trial or receiving investigational therapy within 3 months of enrollment.
  • Presenting with ESRD, RRT, acute kidney injury (AKI), acute kidney disease (i.e., kidney injury or a decline in renal function persisting for ≤3 months) as a primary disease condition at enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Affilicated with Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiao Qiang Ding

    Zhongshan Hospital Affiliated with Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
96 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

March 19, 2026

Study Start

February 27, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2028

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations