China Glomerulonephritis Kidney Transplant Recipient Cohort: A Prospective Multicenter Observational Study
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: AstraZeneca Clinical Study Information Center
- Telefoonnummer: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3-year follow-up
|
Factors associated with GN recurrence after kidney transplantation
|
3-year follow-up
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To assess other clinical events after kidney transplantation and their associated factors
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 3-year follow-up
|
incidence and time to death
|
3-year follow-up
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D9030R00002
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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