PREDNOS 2 Newsletter. randomised controlled trial (RCT).

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1 PREDNOS 2 Newsletter Issue 18 December 2017 Full Title: Short course daily prednisolone therapy at the time of upper respiratory tract infection (URTI) in children with relapsing steroid sensitive nephrotic syndrome (SSNS) Short Title: The PREDNOS 2 Study Welcome to the 18th issue of the PREDNOS 2 Newsletter! Since PREDNOS 2 opened on 22 nd February 2013, 303 patients have been recruited into the study and 122 centres now have full approvals in place. We would like to continue passing on our thanks to all of the PREDNOS 2 collaborators for your ongoing hard work and support. We are currently behind our recruitment target. 303 participants currently recruited out of a target of 336 for the end of November We ask for you to please keep screening for any potentially suitable patients If half of our centres could randomise just one more patient we would reach our recruitment target! We would like to thank Dr Dermot Dalton at North Devon District Hospital, Dr Caroline Jones at Royal Liverpool Children s Hospital (Alder Hey), Dr Chris Upton at Norfolk and Norwich University Hospital, Dr Muhammad Javed at Manor Hospital (Walsall), Dr Junaid Solebo at Queen s Hospital (Romford), Dr Ignatius Losa at Macclesfield District General Hospital, Prof Nick Webb at Royal Manchester Children s Hospital, Dr Sally Johnson at Great North Children s Hospital, and all of their teams for randomising patients in October/November Please send in your screening logs to the PREDNOS 2 study office if you haven t done so already. In order to monitor recruitment as closely as possible, the study team would greatly appreciate PREDNOS 2 sites contacting us if they are experiencing any particular issues with recruitment so that we can provide support in any way we can. If you are aware of any potential patients please inform the study team to help us monitor recruitment! Design: Phase III double blind Aim: To evaluate the effectiveness of a six day course of daily prednisolone therapy at randomised controlled trial (RCT). the time of upper respiratory tract infection (URTI) in reducing the development of subsequent nephrotic syndrome relapse in children with relapsing SSNS. Population: Children with relapsing steroid sensitive nephrotic syndrome (SSNS) ( 2 relapses in preceding 12 months). Christmas and New Year Arrangements Please note that the PREDNOS 2 study office at BCTU will be closed from: 2.00pm Friday 22 nd December 2017 until 9.00am Thursday 4th Jan The Online Randomisation and Data Entry service will still be available. Please report any SAEs to Prof Nick Webb by during this period: Nicholas.Webb@mft.nhs.uk PREDNOS 2 Newsletter, Issue 18, December 2017 Page 1

2 Pharmacy Christmas Arrangements Birmingham Children s Hospital Pharmacy will only be able to send out PREDNOS 2 study medication on the following days: full service as normal up until 1pm on Monday 18 th December 2017, and full service will resume Tuesday 2 nd January The pharmacy will actually be closed after Friday 22 nd December 2017 until opening again on Wednesday 27 th December 2017, and closed after Friday 29 th December 2017 until opening again Tuesday 2 nd January Once a patient has been randomised into the study please remember to send the original prescription form and a copy of the consent form to BCH Pharmacy as soon as possible. PREDNOS 2 Recruitment We are pleased to announce we now have 122 centres fully approved to randomise patients into PREDNOS2, with the assistance of the NIHR Clinical Research Network (CRN): Children. Please see recruitment by NIHR CRN: Children Region below: The graph below shows recruitment by month against revised targets: PREDNOS 2 Newsletter, Issue 18, December 2017 Page 2

3 Participating in PREDNOS 2 The study is currently taking place in 122 centres across the UK with the assistance of the NIHR Clinical Research Network: Children. The table below shows the current PREDNOS 2 sites: Recruitment at sites Thank you to everyone who is involved in the process of patient selection, screening and randomisation Data Clarification System at sites for the PREDNOS 2 study. Without the continued support and effort made by staff working on the The trials team will be implementing a new data clarification system, in which signed hard copy responses study it would not be possible to run, so a big thank you again to you all! will be required from sites for queries raised. By signing the query response, it will be recognised that the delegated member of staff at site is granting permission for the trials team at BCTU to make the outlined Important Reminders and Top Tips changes to the trial data on their behalf, and so the team will then amend the database to reflect this. A separate Parental responsibility outlining and the Consent new data clarification process in more detail will be circulated in the near future. Details of the informed consent discussions should be recorded in the patient medical notes in accordance with Good Clinical Practice (GCP). This should include date of discussion, the name of the study, outcome of the discussion, version number of the PIS given to patient, version number of ICF signed and date consent received, and that the person signing the consent form on behalf of the child has been determined to have the parental responsibility to do so. If a translator has been used this should be noted in the patient medical notes. Where consent is obtained on the same day that the study related assessments are due to start, a note should be made in the patient medical notes as to what time the consent was obtained and what time the procedures started. A copy of the PIS should be added to the patient medical notes. PREDNOS 2 Newsletter, Issue 18, December 2017 Page 3

4 Study Medication Compliance: Parents/participants should be reminded to bring all pots of study medication (unopened, opened and empty) to each 3-monthly study assessment visit in order for compliance to be assessed. URTI Reporting Issues: The number of participants completing the 12 month follow-up without experiencing at least one URTI still remains higher than originally expected. Please could we remind sites of the following to ensure URTIs are reported: - At each assessment visit please ensure the family understand the criteria for an URTI and that study medication should be commenced each and every time the participant meets the criteria for an URTI during the 12 month follow-up period. - Centres with participants currently in the study will have been sent further PREDNOS 2 Study Reminder URTI magnets to give out to parents/participants at their next assessment. - Parents/participants should be reminded to contact their local site or the PREDNOS 2 hotline ( ) before or within 24 hours of commencing study medication. - Ensure the correct information is given to the parents/participants on how to administer study medication once the criteria for an URTI have been met. Details on correct dosing of study drug can be found in the protocol version 2.0 Section 4.8. Participants who become 16 years old whilst in the study: If your centre randomises a patient aged 15 years old and they will become 16 years old during their 12 month follow-up period please bear in mind the following: if it is in your site s SOPs to reconsent patients in CTIMPs once they turn 16 then please document the consent process in the patient notes and record this in the ISF, and keep copies of the PIS and completed consent forms in the patient notes and ISF. Always document in the patient notes the discussion you have with the patient once they turn 16 years old so as it is shown whether or not they are happy to remain in the study and also document on the CRF that the participant has stated they are happy to remain in the study, where this would have previously been the parent. Training for new staff working on PREDNOS 2 If you have any changes to the staff working on PREDNOS 2 at site, please let us know. You should update the delegation log and send an up to date CV and GCP certificate to the study team at BCTU. If any new or existing staff would like to arrange one-to-one training about the study, please contact Helen Bodenham- Chilton, the PREDNOS 2 Trial Coordinator. The PREDNOS 2 team are always happy to help so please contact us if you have any questions! PREDNOS 2 Newsletter, Issue 18, December 2017 Page 4

5 Study Co-Sponsors: University of Birmingham and Central Manchester University Hospitals NHS Foundation Trust (Ref: RG_12-188) EUDRACT No: CTA: 21761/0281/ Approval: 28th Nov 2012 REC Ref No.: 12/NW/0766 North West GM Central Approval: 4th Dec 2012 Funding: National Institute for Health Research Health Technology Assessment programme (NIHR HTA). Ref: 11/129/261 The PREDNOS 2 trial has been adopted by the NIHR Clinical Research Network: Children The PREDNOS 2 study team are always here to help. For further information about the PREDNOS 2 study please contact us: PREDNOS 2 Chief Investigator: Prof Nicholas Webb, Royal Manchester Children s Hospital nicholas.webb@mft.nhs.uk PREDNOS 2 Hotline (for urgent clinical queries): Tel: PREDNOS 2 WEBSITE: PREDNOS 2 FAX: PREDNOS 2 Study Team Telephone: PREDNOS 2 prednos2@trials.bham.ac.uk POSTAL ADDRESS: PREDNOS 2 Study Office, Birmingham Clinical Trials Unit (BCTU) Institute of Applied Health Research College of Medical and Dental Sciences Public Health Building University of Birmingham Edgbaston Birmingham B15 2TT Telephone Randomisation (available 9am-5pm Monday to Friday): Online Randomisation (available 24hrs): PLEASE NOTE THE CHRISTMAS ARRANGMENTS FOR BCTU AND PHARMACY ABOVE. Thank you for taking the time to read the latest PREDNOS 2 newsletter. We would like to wish you a very Merry Christmas and a Happy New Year. PREDNOS 2 Newsletter, Issue 18, December 2017 Page 5