Halimi, Jean-Michel
Al-Dakkak, Imad
Anokhina, Katerina
Ardissino, Gianluigi
Licht, Christoph
Lim, Wai H.
Massart, Annick
Schaefer, Franz
Walle, Johan Vande
Rondeau, Eric
Clinical trials referenced in this document:
Documents that mention this clinical trial
Clinical characteristics and outcomes of a patient population with atypical hemolytic uremic syndrome and malignant hypertension: analysis from the Global aHUS registry
https://doi.org/10.1007/s40620-022-01465-z
Funding for this research was provided by:
Alexion, AstraZeneca Rare Disease, Boston, MA
Article History
Received: 30 March 2022
Accepted: 6 September 2022
First Online: 24 September 2022
Change Date: 3 October 2022
Change Type: Update
Change Details: ESM update.
Declarations
:
: Jean-Michel Halimi has received honoraria and/or travel grants from Ablynx; Alexion, AstraZeneca Rare Disease; AstraZeneca; Bayer; Bouchara Recordati, Fresenius; GlaxoSmithKline; Mundipharma; MSD; Roche Servier; Sanofi; and Vifor Fresenius. Imad Al-Dakkak is an employee and stockholder of Alexion, AstraZeneca Rare Disease. Katerina Anokhina is an employee and stockholder of Alexion, AstraZeneca Rare Disease. Gianluigi Ardissino has received honoraria from Alexion, AstraZeneca Rare Disease; Alnylam; Roche; Novartis; and Eligo Bioscience. Christoph Licht has received honoraria from Alexion, AstraZeneca Rare Disease; Apellis; Genentech – Hoffman La Roche; Novartis; unrestricted research grants from Alexion, Aurin Biotech, Fresenius and Pfizer; and was Chair of the Global aHUS Registry (2013–2020). Wai Lim has received speaker fees and/or education grants from Alexion, AstraZeneca Rare Disease; Novartis; and Astellas. Annick Massart has received honoraria from Alexion, AstraZeneca Rare Disease and Amicus Therapeutics. Franz Schaefer has received honoraria from Alexion, AstraZeneca Rare Disease; Alnylam; Astellas; AstraZeneca; Bayer; Otsuka; Roche; and is Chair of the Global aHUS Registry. Johan Vande Walle has received honoraria from Alexion, AstraZeneca Rare Disease; Alnylam; Astellas; Bayer; Chies; Ferring; Kyowa Kyrin; Otsuka; is a member of the Global aHUS Registry; and is chair of the National aHUS Registry. Eric Rondeau has received honoraria, fees and grants from Alexion, AstraZeneca Rare Disease.
: This was a multicenter study comprising many different sites of enrollment. Federal, provincial, and local regulations and International Conference on Harmonization guidelines, if relevant, required that approval was obtained from an Ethics Committee (EC)/IRB prior to participation of patients in research studies. Where required and prior to the study onset, the EC/IRB must have approved the protocol, informed consent, advertisements to be used for patient recruitment, and any other written information regarding this study to be provided to the patient or the patient’s parents/legal guardian. The sites maintained and made available for review by the sponsor or its designee documentation of all EC/IRB approvals and of the EC/IRB compliance with International Conference on Harmonization Guidance E6: Good Clinical Practice, if relevant. All EC/IRB approvals were signed by the EC/IRB chairman or designee and identified the EC/IRB name and address, the clinical protocol by title and/or protocol number, and the date approval and/or favorable opinion was granted. The investigator conducted all aspects of this study in accordance with all national, provincial, and local laws of the pertinent regulatory authorities.
: A written informed consent was obtained from each patient prior to participation in the study. The sponsor or its designee could provide an informed consent template to the sites, if required. If the site made any The sponsor or its designee could provide an informed consent template to the sites, if required. If the site made any institution-specific modifications, the sponsor or its designee could review the consent prior to IRB/EC submission. The investigator or the sponsor would then submit the approved, revised consent to the appropriate IRB/EC for review and approval prior to the start of the study. If the consent form was revised during the course of the study, all active participating patients to whom the revision may have had an impact must have signed the revised form. Before recruitment and enrollment, each patient was given a full explanation of the study and was allowed time to read the approved informed consent form. Once the investigator was assured that the individual understood the implications of participating in the study, the patient was asked to give consent to participate in the study by signing the informed consent form. The investigator provided a copy of the signed informed consent to the patient. The original form was maintained in the study files at the site.