NCT04084145

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,004

participants targeted

Target at P75+ for all trials

Timeline
81mo left

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2016Dec 2032

Study Start

First participant enrolled

July 27, 2016

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

April 3, 2025

Status Verified

December 1, 2023

Enrollment Period

16.4 years

First QC Date

March 5, 2019

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of participants with CKD progression

    Progression of chronic kidney disease to kidney failure (defined as sustained decrease to \<15mL/min/1.73m2 or initiation of kidney replacement therapy).

    5 years

  • Number of participants who experience a major acute cardiovascular event

    Cardiac death, non-fatal myocardial infarction, cerebral infarction or intracerebral haemorrhage , arterial revascularisation

    5 years

Secondary Outcomes (33)

  • Rate of GFR decline

    5 years

  • Rate of GFR decline

    10 years

  • Rate of GFR decline

    15 years

  • Number of participants with CKD progression

    5 years

  • Number of participants with CKD progression

    10 years

  • +28 more secondary outcomes

Study Arms (1)

CKD

Chronic Kidney Disease stage 1 - 4 followed up in secondary care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from nephrology clinics at multiple (planned to start with 11) participating sites. Control participants (without CKD) will be recruited from among hospital staff members, people attending diabetes clinics and the general public.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Derby Hospital

Derby, Derbyshire, DE22 £NE, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

Related Publications (4)

  • Taal MW, Lucas B, Roderick P, Cockwell P, Wheeler DC, Saleem MA, Fraser SDS, Banks RE, Johnson T, Hale LJ, Andag U, Skroblin P, Bayerlova M, Unwin R, Vuilleumier N, Dusaulcy R, Robertson F, Colby E, Pitcher D, Braddon F, Benavente M, Davies E, Nation M, Kalra PA. Associations with age and glomerular filtration rate in a referred population with chronic kidney disease: methods and baseline data from a UK multicentre cohort study (NURTuRE-CKD). Nephrol Dial Transplant. 2023 Oct 31;38(11):2617-2626. doi: 10.1093/ndt/gfad110.

  • Phillips T, Harris S, Aiyegbusi OL, Lucas B, Benavente M, Roderick PJ, Cockwell P, Kalra PA, Wheeler DC, Taal MW, Fraser SDS. Potentially modifiable factors associated with health-related quality of life among people with chronic kidney disease: baseline findings from the National Unified Renal Translational Research Enterprise CKD (NURTuRE-CKD) cohort. Clin Kidney J. 2024 Jan 19;17(2):sfae010. doi: 10.1093/ckj/sfae010. eCollection 2024 Feb.

  • Lucas BJ, Cockwell P, Fraser SDS, Kalra PA, Wheeler DC, Taal MW. Associations With Baseline Blood Pressure Control in NURTuRE-CKD. Kidney Int Rep. 2024 Feb 15;9(5):1508-1512. doi: 10.1016/j.ekir.2024.02.013. eCollection 2024 May. No abstract available.

  • McDonnell T, Kalra PA, Vuilleumier N, Cockwell P, Wheeler DC, Fraser SDS, Banks RE, Taal MW. The Impact of Primary Renal Diagnosis on Prognosis and the Varying Predictive Power of Albuminuria in the NURTuRE-CKD Study. Am J Nephrol. 2025;56(1):1-12. doi: 10.1159/000541770. Epub 2024 Oct 4.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, urine, DNA, renal biopsy tissue

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maarten Taal, MBChB

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2019

First Posted

September 10, 2019

Study Start

July 27, 2016

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

April 3, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Application for use of data to the independent NURTuRE Steering Group, facilitated by Kidney Research UK

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
variable depending on applications
Access Criteria
Approval of application by independent NURTuRE Steering Group
More information

Locations