Who is sponsoring NCT05465863?

NCT05465863 is sponsored by Istanbul University - Cerrahpasa.

What drugs are being tested in NCT05465863?

Interventions in NCT05465863: SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®).

What condition does NCT05465863 study?

NCT05465863 studies Chronic Kidney Disease 5D, Chronic Kidney Disease 5T.

Is NCT05465863 still recruiting?

NCT05465863 is currently completed. Last updated 20 July 2022.

Last reviewed 2022-07-20 · How we verify

NCT05465863

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Humoral and Cellular İmmune Response to SARS-CoV-2 mRNA BNT162b2 Vaccine in Children With Chronic Kidney Diseases

Completed NA Last updated 20 July 2022

What this trial tests

NA trial testing SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) in Chronic Kidney Disease 5D in 101 participants. Completed in 1 March 2022.

Timeline

1 September 2021

Primary endpoint
1 February 2022

1 March 2022

Quick facts

Lead sponsor	Istanbul University - Cerrahpasa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	101
Start date	1 September 2021
Primary completion	1 February 2022
Estimated completion	1 March 2022
Sites	6 locations across Turkey (Türkiye)

Drugs / interventions tested

SARS-CoV-2 mRNA BNT162b2 vaccine (Pfizer-BioNTech®) — full drug profile →

Conditions studied

Chronic Kidney Disease 5D — all drugs for Chronic Kidney Disease 5D →
Chronic Kidney Disease 5T — all drugs for Chronic Kidney Disease 5T →

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 12 to 19, any sex, with Chronic Kidney Disease 5D or Chronic Kidney Disease 5T. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Coronavirus 2019 (COVID-19) infection is associated with higher morbidity and mortality in adult patients on dialysis, and kidney transplant recipients (KTRs). Although children had lower morbidity and mortality, KTRs are more vulnerable than healthy children. It has already known that the general immune responses to vaccines, which are currently in practice (attenuated, conjugated, or recombinant) were lower than healthy controls in children and adolescents on dialysis and with a kidney transplantation. Uremic milieu and immunosuppressive drugs are the factors causing impaired immune response in this group of patients. The new mRNA vaccine technology is used worldwide including children and adolescents during the pandemic. Studies have demonstrated lower immune response to new SARS-CoV-2 mRNA vaccine in adult KTRs. However, there is limited data about vaccine-induced immune response in children and adolescent with renal replacement therapy. The aim of this study was to assess immune response to SARS-CoV-2 mRNA BNT162b2 and its clinical and laboratory correlates in children and adolescent KTRs. Humoral immune response was assessed by anti-SARS-CoV-2 immunoglobulin G (Anti-S IgG) and its clinical correlate neutralizing antibody (nAb). Cellular immune response was assessed with SARS-CoV-2 specific Interferon ɣ release assay (IGRA).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Humoral and cellular immune response to SARS-CoV-2 mRNA BNT162b2 vaccine in pediatric kidney transplant recipients compared with dialysis patients and healthy children.
Gulmez R, Ozbey D, Agbas A, Aksu B, et al · · 2023 · cited 7× · PMID 36459243 · DOI 10.1007/s00467-022-05813-w

Verify or expand the search:

Other recruiting trials for Chronic Kidney Disease 5D

Currently open trials in the same condition.

NCT07045155 — Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis · Phase 4 · recruiting
NCT05071131 — Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease · NA · recruiting

Other Istanbul University - Cerrahpasa trials

Trials by the same sponsor.

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NCT07378449 — The Effect of Hand Exercise Hoops on Labour Pain · NA · not yet recruiting
NCT07293000 — Evaluating Two Nursing Interventions to Prevent Urinary Retention After Spinal Anesthesia · NA · not yet recruiting
NCT07562880 — Validity and Reliability of the Exercise-Related Health Beliefs Attitude Scale in Geriatric Individuals · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05465863 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Istanbul University - Cerrahpasa
Last refreshed: 20 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05465863.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing