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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess the incidence of GN recurrence after kidney transplantation and its influencing factors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3-year follow-up
|
Factors associated with GN recurrence after kidney transplantation
|
3-year follow-up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess other clinical events after kidney transplantation and their associated factors
Tidsramme: 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
Tidsramme: 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
Tidsramme: 3-year follow-up
|
incidence and time to death
|
3-year follow-up
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D9030R00002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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