NCT07783737

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet 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

First Submitted

Initial submission to the registry

August 21, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 24, 2026

Expected
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

3.9 years

First QC Date

August 21, 2026

Last Update Submit

August 21, 2026

Conditions

Glomerulonephritis Kidney Transplant

Keywords

glomerulonephritisGN

Outcome Measures

Primary Outcomes (3)

  • To assess the incidence of GN recurrence after kidney transplantation and its influencing factors

    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 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

    Factors associated with GN recurrence after kidney transplantation

    3-year follow-up

Secondary Outcomes (3)

  • To assess other clinical events after kidney transplantation and their associated factors

    3-year follow-up

  • To assess other clinical events after kidney transplantation and their associated factors

    3-year follow-up

  • To assess other clinical events after kidney transplantation and their associated factors

    3-year follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a confirmed diagnosis of primary GN before kidney transplantation

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glomerulonephritis

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2026

First Posted

August 25, 2026

Study Start (Estimated)

September 24, 2026

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.
More information