The Leicester City and County Chronic Kidney Disease Cohort

NCT03135002 | Completed

• 1 other identifier: 0576
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is estimated to affect 6-8% of the adult population and is independently associated with increased cardiovascular (CV) disease risk. This risk increases as CKD advances both in relation to worsening glomerular filtration rate and development of proteinuria. The overall cost of CKD to the NHS (National Health Service) in England has been estimated as £1.45 billion per annum, or 1.3% of the NHS's total budget. This includes £175 million, or 13% of the CKD budget, annually spent in relation to 19,000 excess myocardial infarctions and strokes related to CKD. The epidemiology of CKD in primary care is poorly studied. This is particularly the case in non-white populations who have an independent higher risk of progression to end stage renal failure (requiring dialysis or transplantation), CV events and death. Further, CV disease risk in CKD remains poorly described beyond simple risk stratification by CKD stage. A recent systematic review identified some CKD-specific CV disease risk scores. However, all the risk scores had significant methodological limitations, such as a lack of external validation or the perception that they were not 'clinically useful'. The Leicester City and County Chronic Kidney Disease (LCC-CKD) cohort will be created from anonymised GP (general practice) records of individuals with CKD. We will aim to retrospectively create a cohort with 5 years follow-up to the present day. In addition, a present day cohort will be created to both aid research and provide data for practices and clinical commissioning groups for quality improvement (QI) purposes. We will aim to include 30,000 individuals with CKD in the cohort. The principal objectives of the study are:

1. 1.To study the natural history of CKD in a multi-ethnic primary care setting
2. 2.To contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD

Conditions

Chronic Kidney Diseases; Cardiovascular Diseases; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• Cardiovascular disease events

  Major cardiovascular events, to study the natural history of CKD in a multi-ethic primary care setting and to contribute to the creation of a risk prediction tool for heart attacks and strokes in CKD

  5 years

Secondary Outcomes (2)

• All-cause mortality

  5 years

• Hospitalisation

  5 years

Interventions

Other OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with non-endstage chronic kidney disease

You may qualify if:

• Practice Level - all primary care practices within the 3 Clinical Commissioning Groups participating in the study.
• Patient Level - any individual 18 years or over with an MDRD (Modification of Diet in Renal Disease) or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) eGFR (estimated glomerular filtration rate) less than 60ml/minute/1.73m2, proteinuria or a Read code CKD diagnosis.

You may not qualify if:

• Aged less than 18 years of age
• Endstage renal failure i.e. already receiving dialysis or with a kidney transplant.

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator
• Leicester City Clinical Commissioning Group: collaborator
• West Leicestershire Clinical Commissioning Group: collaborator
• East Leicestershire Clinical Commissioning Group: collaborator

Study Sites (1)

University of Leicester

Leicester, Leicestershire, LE1 7RH, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 1, 2017
• Study Start: January 10, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 30, 2020

Record last verified: 2019-05

Locations

GB (1)