China Glomerulonephritis Kidney Transplant Recipient Cohort: A Prospective Multicenter Observational Study

August 21, 2026 updated by: AstraZeneca

This is a prospective observational study aimed at establishing a prospective observational cohort of patients with a confirmed diagnosis of glomerulonephritis (GN) before kidney transplantation in China. Information will be collected on the epidemiology of GN recurrence after kidney transplantation, as well as the outcomes and treatment of the primary disease following kidney transplantation, to provide evidence for subsequent clinical studies, drug development, and translational research.

Approximately 300 patients with a confirmed diagnosis of GN before transplantation will be prospectively enrolled. Clinical data will be collected during screening, kidney transplantation, and a 3-year post-transplant follow-up. The frequency of follow-up visits is every 3 months in the 1st year after transplantation, and every 6 months during the 2nd to 3rd years, with a total of 8 follow-up visits. The study will be conducted at 10 sites across China.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a confirmed diagnosis of primary GN before kidney transplantation

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Diagnosed with primary GN based on clinical guidelines and/or expert consensus
  • Successfully matching completed and confirmed to be scheduled for kidney transplantation.

Exclusion Criteria:

  • History of organ transplantation or planned multiple organ transplantation.
  • Complicated with malignancy.
  • Failure to undergo kidney transplantation for any reason.
  • Unable to provide written informed consent form (ICF).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
Time Frame: 3-year follow-up
Incidence of GN recurrence after kidney transplantation
3-year follow-up
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
Time Frame: 3-year follow-up
Time to GN recurrence after kidney transplantation (months)
3-year follow-up
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
Time Frame: 3-year follow-up
Factors associated with GN recurrence after kidney transplantation
3-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess other clinical events after kidney transplantation and their associated factors
Time Frame: 3-year follow-up
incidence and time to rejection
3-year follow-up
To assess other clinical events after kidney transplantation and their associated factors
Time Frame: 3-year follow-up
incidence and time to renal allograft loss
3-year follow-up
To assess other clinical events after kidney transplantation and their associated factors
Time Frame: 3-year follow-up
incidence and time to death
3-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 24, 2026

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9030R00002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests 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.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.

Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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