RaDaR Ethics Amendment Approved

 

The latest RaDaR amendment has now been approved by Ethics. The main changes concern clarification that RaDaR consent covers Patient View Sign-up, subject to local availability, and that patients consent to being contacted directly by a member of the central RaDaR team and/or their Rare Disease Group Lead regarding information events or further research studies.

The amendment also allows for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will enable a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future.

Copies of the new documents have been sent to all current sites and are also available from the Criteria and Consent page.

If you have any queries about the amendment please contact Melanie.Dillon@RenalRegistry.nhs.uk

RaDaR Ethics amendment submitted

Following a review of our revised consent documents by NHS Digital, we have just submitted the latest RaDaR amendment to the South West – Central Bristol Research Ethics Committee.

The main changes concern clarification that RaDaR consent covers Patient View Sign-up, subject to local availability, and that patients consent to being contacted directly by a member of the central RaDaR team and/or their Rare Disease Group Lead regarding information events or further research studies.

The amendment will also allow for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will allow for a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future.

No action is required on behalf of the sites at present. We will everyone informed as to the progress of this amendment and let you know when it is approved.

If you have any queries about the amendment please contact Melanie.Dillon@RenalRegistry.nhs.uk

Primary Hyperoxaluria Webinar, 15th August

 

 

The Oxalosis & Hyperoxaluria Foundation (OHF) and Dicerna Pharmaceuticals invite you to participate in a webinar on Tuesday, August 15, 2017 at 16.00 hours GMT to discuss research presented by Dicerna during the 12th International Workshop on Primary Hyperoxaluria in Tenerife, Spain in July.

At the meeting, Dicerna announced the expansion of its drug development programs to encompass all forms of primary hyperoxaluria (PH). Based on new pre-clinical data presented in Tenerife, the investigational therapy DCR-PHXC has the potential to treat all forms of PH.

The webinar will provide an overview of the following research topics:

• The need for new treatment strategies for all types of PH
• The role of the LDHA gene in the pathogenesis of PH
• The DCR-PHXC preclinical data demonstrate potent, durable, and precise knockdown of LDHA in animal models of PH1, PH2 and idiopathic PH, and show a simple, direct linear relationship between LDHA inhibition and oxalate production
• Clinical development plans and timelines for DCR-PHXC

Speakers

• Kim Hollander, Executive Director, Oxalosis & Hyperoxaluria Foundation

• Dr Sally-Anne Hulton, M.D. Paediatric Nephrology, Birmingham Children’s Hospital UK

• Ralf Rosskamp, M.D. Chief Medical Officer, Dicerna Pharmaceuticals

Participate

Questions

Ask a question by emailing: julieb@ohf.org (subject line: Dicerna Webinar) by Sunday, August 13, 2017.

New aHUS website

 

The National Renal Complement Therapeutics Centre in Newcastle has launched a new website – www.atypicalHUS.co.uk – containing information for both patients and clinicians on atypical haemolytic uraemic syndrome and C3 glomerulopathy. The site contains information about the diagnosis and management of aHUS, including patients who have end-stage renal failure and may benefit from the prophylactic use of eculizumab at time of renal transplantation.

Proposed Ethics Amendment for RaDaR

 

The RaDaR Operational Management Board and Rare Disease Group Leads have agreed to apply for an Ethics amendment to clarify the fact that RaDaR consent covers Patient View sign-up, subject to availability at individual renal units.

The proposed amendment will also allow for data linkage to other registries, including the Hospital Episode Statistics (HES) and Office for National Statistics (ONS) databases. This will allow for a far more comprehensive RaDaR data-set than is currently available with manual data entry. It will also allow for longitudinal follow-up of patients who have previously consented to condition-specific research studies, or who do so in the future. 

In addition, it is proposed to ask patients to consent to being contacted directly by a member of the central RaDaR team, regarding information events or further research studies. Such communication would always be approved by the patient’s Consultant before being sent out and will largely be circulated via Patient View.  

Approval will be sought from NHS Digital’s data Access Request Service (DARS). 

It is aimed to submit the Ethics amendment by the of September. Please continue to recruit patients to RaDaR in the meantime, using the current consent documents.

Further details will follow in the coming weeks but we would welcome suggestions over the proposed amendment to Melanie.Dillon@RenalRegistry.nhs.uk.

Clinician Educational Meeting on RaDaR & Fabry Disease

 

Prof Detlef Bockenhauer, chair of the Rare Disease Committee of the Renal Association, is hosting a forum to help clinicians and researchers to better understand RaDaR and Fabry Disease in particular. The event will be held during UK Kidney Week on Monday 19th June 2017 at the Pullman Hotel, Kings Dock, Liverpool, L3 4FP

The meeting has been organised by Sanofi Genzyme and will include a buffet dinner.

Places are limited and attendees are asked to RSVP to John Applegate at john@kolcommunications.net

Event Invite