National Unified Renal Translation Research Enterprise - Chronic Kidney Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Nottingham
- Enrollment
- 3,004
- Locations
- 2
- Primary Endpoint
- Number of participants with CKD progression
Study Overview
Brief Summary
Chronic Kidney Disease (CKD) affects around 10% of the adult population and is associated with an increased risk of heart attack, stroke and end stage kidney disease (ESKD). This study aims to better predict who is most likely to progress to ESKD using previously identified risk factors and novel biomarkers in blood and urine samples, along with kidney biopsy tissue. Resources can then be directed to those most at risk of disease progression and other associated conditions such as heart attack and stroke, while those at lower risk can be offered less frequent monitoring.
Detailed Description
3,000 participants will be recruited from nephrology clinics at multiple participating centres (planned to start with 11). 100 control participants (without CKD) will be recruited from among hospital staff members, people attending diabetes clinics and the general public via advertisements placed in the hospitals and in the press.
Study participants with CKD will participate in the study for 12 - 18 months of active follow-up. After that participants will be sent a questionnaire annually by post to assess quality of life (EQ-5D-5L) and health care resource utilisation during the previous year and the investigators will collect outcome data without the need for further study visits; this annual follow-up by questionnaire will continue for 14 years following their second study visit.
Study participants acting as normal controls will attend only a single study visit.
All participants will provide written informed consent prior to undergoing any interventions. After providing written informed consent participants will undergo the following assessments and study procedures:
Medical History: The following data will be collected by interview, questionnaire and examination of the participants' medical records.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age Over 18 years of age
- •Estimated GFR 59-15ml/min/1.73m² or eGFR >60ml/min/1.73m² and urine albumin to creatinine ratio >30mg/mmol
- •Seen at least once in a Nephrology Clinic
- •Willing to participate in two study visits
- •Able to give informed consent and participate in study procedures
Exclusion Criteria
- •Recipient of a solid organ transplant
- •Expected survival less than 1 year (in the opinion of local investigators)
- •Acute kidney injury within 3 months of recruitment
- •Major Acute Cardiovascular Event (MACE) within 3 months of recruitment
- •Participants without CKD - controls Inclusion criteria
- •Age over 18 years of age
- •Willing to participate in one study visit
- •Able to give informed consent and participate in study procedures
- •No evidence of CKD
- •No other major illnesses except for hypertension and type 2 diabetes mellitus (50 participants will have diabetes but no CKD)
- •Exclusion criteria
- •Estimated GFR<60ml/min/1.73m2 in previous 12 months or last available result
- •Urine albumin to creatinine ratio >3mg/mmol in previous 12 months or last available result
- •Previous unilateral nephrectomy or partial nephrectomy
- •Recipient of a solid organ transplant
- •Expected survival less than 1 year (in the opinion of local investigators)
Outcomes
Primary Outcomes
Number of participants with CKD progression
Time Frame: 5 years
Progression of chronic kidney disease to kidney failure (defined as sustained decrease to \<15mL/min/1.73m2 or initiation of kidney replacement therapy).
Number of participants who experience a major acute cardiovascular event
Time Frame: 5 years
Cardiac death, non-fatal myocardial infarction, cerebral infarction or intracerebral haemorrhage , arterial revascularisation
Secondary Outcomes
- Rate of GFR decline(15 years)
- Number of participants with CKD progression(10 years)
- Number of participants who experience a major acute cardiovascular event(15 years)
- Number of participants who die from any cause(15 years)
- Number of participants who progress to end stage kidney disease (ESKD)(15 years)
- Number of participants who experience acute kidney injury (AKI)(15 years)
- Number of participants admitted to hospital with a new diagnosis of cardiac failure(15 years)
- Number of participants with an unplanned hospital admission(15 years)
- Number of participants admitted to hospital with an infection(15 years)
- Number of participants with a new diagnosis of cancer(15 years)
- Number of participants with a hip fracture(15 years)
- Number of participants with progression of chronic kidney disease (CKD) (KDIGO definition)(15 years)