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Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04944433
Recruitment Status : Active, not recruiting
First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
University of Buenos Aires
Information provided by (Responsible Party):
GUILLERMO JAVIER ROSA DIEZ, Hospital Italiano de Buenos Aires

Brief Summary:
It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy. Objectives: To evaluate the safety and efficacy of Coronavirus disease 2019 vaccines in hemodialysis patients.

Condition or disease
Coronavirus Disease 2019 Vaccines Renal Dialysis

Detailed Description:

Given the vulnerability of people with chronic kidney disease to Coronavirus 2019 , leading nephrology societies such as the National Kidney Federation and the American Kidney Foundation have issued statements calling for prioritization of these patients for vaccination. It is unknown whether Coronavirus disease 2019 vaccines confer the same high level of protection in patients with kidney disease as reported for participants in recent trials, who were generally healthy.

Objectives:

  1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine
  2. Determine the levels of Immunoglobulin G antibodies in patients who received a Coronavirus disease 2019vaccine between the time before the first dose, at 21 days, at 40 days and at 120 days after immunization.

Methods Design: Multicenter, observational and analytical study of a prospective cohort of hemodialysis patients 18 years and older who received immunization with a Coronavirus disease 2019 vaccine in the Autonomous City of Buenos Aires in a vaccination plan.

Analysis The proportion of patients with Adverse events presumably attributable to vaccination and immunization will be estimated with its 95% confidence interval. The immunoglobulin G titer for coronavirus type 2 causing severe acute respiratory syndrome will be compared using Generalized Estimating Equations models.

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Study Type : Observational
Estimated Enrollment : 950 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Efficacy of the Coronavirus Disease 2019 Vaccine in Hemodialysis Patients
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : June 9, 2022
Estimated Study Completion Date : July 9, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine [ Time Frame: one year ]
    Estimate the proportion of hemodialysis patients who present events supposedly attributed to vaccines and immunizations after having received a Coronavirus disease 2019 vaccine

  2. To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization [ Time Frame: one year ]
    To assess the change in the levels of Immunoglobulin G (IgG) antibodies from baseline at 21 days, at 40 days and at 120 days after immunization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hemodialysis patients in an immunization plan with a COVID-19 vaccine from the hemodialysis centers of the Autonomous City of Buenos Aires
Criteria

Inclusion Criteria:

  • Patients over 18 years of age on hemodialysis in an immunization plan with a Coronavirus disease 2019 vaccine.

Exclusion Criteria:

  • Contraindication to receive the vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944433


Locations
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Argentina
Universidad de Buenos Aires Facultad de Medicina
Buenos Aires, Caba, Argentina, 1121A6B
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Ministerio de Salud de Ciudad Autónoma de Buenos Aires
University of Buenos Aires
Investigators
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Principal Investigator: Guillermo IP Rosa Diez, MD Hospital Italiano de Buenos Aires
Study Chair: Jorge SI Geffner University of Buenos Aires
Study Chair: Fernando SI Lombi Sociedad Argentina de Nefrología
Study Chair: Marina SI Papaginovic Sociedad Argentina de Nefrología
Study Chair: Ricardo SI Heguilen Sociedad Argentina de Nefrología
Study Chair: Luciana Fernandez SI Paganti Sociedad Argentina de Nefrología
Study Chair: Soledad SI Crucelegui Hospital Italiano de Buenos Aires
Study Chair: Vanina SI Pagotto Hospital Italiano de Buenos Aires
Additional Information:
Publications of Results:
Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8. Erratum in: Lancet. 2021 Jan 9;397(10269):98.

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Responsible Party: GUILLERMO JAVIER ROSA DIEZ, Principal investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT04944433    
Other Study ID Numbers: 7412
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GUILLERMO JAVIER ROSA DIEZ, Hospital Italiano de Buenos Aires:
Seroepidemiologic Studies
Renal Dialysis
Coronavirus disease 2019 Vaccines
Additional relevant MeSH terms:
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Coronavirus Infections
COVID-19
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases