Salford Kidney Study
Research type
Research Study
Full title
Salford Kidney Study
IRAS ID
191925
Contact name
Philip A Kalra
Contact email
Duration of Study in the UK
9 years, 11 months, 30 days
Research summary
Patients with kidney disease exhibit unique, complex patterns of illness and complications. Establishing factors which cause or predict these requires large epidemiological, laboratory, and tissue datasets. The Salford Kidney Research team are able to deliver this, having pre-existing similar studies on which to build, and access to comprehensive electronic patient records for both local primary and secondary care.\n \nAdult patients with kidney disease referred to the renal services at Salford Royal Hospital are recruited if written informed consent is obtained. Patients are reviewed annually at routine visits until death, discharge, or withdrawal from the study. They will undergo clinical history, and cardiovascular investigations. They will have extra blood samples taken during their usual phlebotomy, and these and part of their routine urine samples will be stored in the Salford Biorepository for use in laboratory biomarker, genomic, and epigenetic studies. Patients will be assigned to one or more sub-groups depending on their specific kidney disease and whether or not they are receiving dialysis. This will determine whether the patient is approached for inclusion in an echocardiogram and ECG sub-study. Patients may move from one group to another as their clinical status changes, so consent to the sub-study may occur after initial enrolment. \n\nSupporting health and care data such as GP records, other hospital records, and cause of death from the Health and Social Care Information Centre, will be sought to provide co-morbidity and end point information such as cardiovascular events and death. If patients are discharged from the renal services, they will no longer undergo annual assessment but provided that the patient consents, outcome data will continue to be collected. \n\nThe study will incorporate the data and samples collected in the CRISIS study, such that the vast amount of epidemiological data already amassed can continue to be used in conjunction with this updated study. All surviving CRISIS patients will be re-consented into the Salford Kidney Study, as will surviving patients presently participating in our renovascular prospective observational study. The database will not include any patient-specific identifiers, and blood and urine samples will be stored in anonymised fashion, identifiable by study number only. [COVID-19 amendment 01/05/2020] 1. Addition of targeted recruitment and additional samples from patients with COVID-19 infection (A11, A12, A13, A22, protocol and PIS). In order to understand the effects of the 2020 COVID-19 outbreak on kidney patients, we will prospectively recruit\npatients with a confirmed diagnosis (by PCR) of COVID-19 infection, or those suspected as having had the infection,\nas soon as possible after that diagnosis. Patients will be approached by a member of the research team, following\nappropriate safety precautions, either at a dialysis appointment following confirmation or suspicion of COVID-19\ninfection, which may be in the dialysis unit, or for inpatients, whilst being managed on the ward. During the\nrecruitment stage participants involved in the COVID-19 sub-studies will only undergo collection of a minimum data\nset as well as blood tests. However, participants may be requested to provide detailed demographic details and\ncompletion of the detailed questionnaire at a later date. There are two particular sub-studies that the research team will undertake. For both COVID studies blood samples\nwill be taken at more frequent intervals, to allow investigation of the immune response in those patients receiving\nhaemodialysis (COVID sub-study 1) and also the time course for clearance of COVID-related cytokines and\ninflammatory mediators in patients receiving renal replacement therapy (COVID sub-study2). The blood samples will\nbe taken from dialysis arterio-venous fistulae or from dialysis catheters and no venepuncture will be required.\n2. Change to recruitment and consent process, to clarify that any member of the research team may obtain consent if\nthey have been delegated to do so by the Principal Investigator (A30-1 and protocol).\nThis change has been made to reflect the current practice within our research delivery teams, enabling research\nassistants and practitioners to recruit to research studies, where they are appropriately trained and experienced, and\nthe PI has added them to the study delegation log.\n3. Confirmation that the full demographic questionnaire and interview does not need to be completed at the first visit\n(A13 and protocol). This change reflects the practical experience of those staff recruiting participants to the study. Participants do not\nalways have time or wish at the end of their clinic appointment to complete the questionnaires and interview, and this\ncan easily be deferred to another occasion without affecting the conduct or science of the study.\n4. Clarification that participants do not need to participate in all study elements.\nProtocol and PIS amended to clarify that patients do not need to participate in all the elements of the study, with collection of a minimum dataset and blood samples as the minimum.\n5. Protocol clarified to replace ’each visit’ with ’annual visit’.\n6. Administrative revisions\na) protocol updated to reflect current study team (no change to CI or PI)\nb) correction to REC and R&D references\nc) protocol updated to reflect current sponsor representative details\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0818
Date of REC Opinion
1 Feb 2016
REC opinion
Further Information Favourable Opinion