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National Unified Renal Translation Research Enterprise - Chronic Kidney Disease (NURTuRE-CKD)

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ClinicalTrials.gov Identifier: NCT04084145
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Kidney Cancer UK
UK Renal Registry
University of Bristol
University of Birmingham
University of Southampton
University of Geneva, Switzerland
NIHR National Biosample Centre
UCB Pharma Ltd
Evotec International GmbH
AbbVie
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease
Chronic Kidney Diseases

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Unified Renal Translation Research Enterprise - Chronic Kidney Disease
Actual Study Start Date : July 27, 2016
Estimated Primary Completion Date : December 31, 2032
Estimated Study Completion Date : December 31, 2032

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
CKD
Chronic Kidney Disease stage 1 - 4 followed up in secondary care



Primary Outcome Measures :
  1. Number of participants with CKD progression [ Time Frame: 5 years ]
    Progression of CKD as defined by a 50% reduction in estimated GFR or development of CKD stage 5

  2. 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 Outcome Measures :
  1. Number of participants with CKD progression [ Time Frame: 10 years ]
    Progression of CKD as defined by a 50% reduction in estimated GFR or development of ESKD

  2. Number of participants with CKD progression [ Time Frame: 15 years ]
    Progression of CKD as defined by a 50% reduction in estimated GFR or development of ESKD

  3. Number of participants who experience a major acute cardiovascular event [ Time Frame: 10 years ]
    Cardiac death, non-fatal myocardial infarction, cerebral infarction or intracerebral haemorrhage

  4. Number of participants who experience a major acute cardiovascular event [ Time Frame: 15 years ]
    Cardiac death, non-fatal myocardial infarction, cerebral infarction or intracerebral haemorrhage

  5. Number of participants who die from any cause [ Time Frame: 5 years ]
    Death from any cause

  6. Number of participants who die from any cause [ Time Frame: 10 years ]
    Death from any cause

  7. Number of participants who die from any cause [ Time Frame: 15 years ]
    Death from any cause

  8. Number of participants who progress to end stage kidney disease (ESKD) [ Time Frame: 5 years ]
    Development of end stage kidney disease (ESKD = eGFR <15mL/min/1.73m2)

  9. Number of participants who progress to end stage kidney disease (ESKD) [ Time Frame: 10 years ]
    Development of end stage kidney disease (ESKD = eGFR <15mL/min/1.73m2)

  10. Number of participants who progress to end stage kidney disease (ESKD) [ Time Frame: 15 years ]
    Development of end stage kidney disease (ESKD = eGFR <15mL/min/1.73m2)

  11. Number of participants who experience acute kidney injury (AKI) [ Time Frame: 5 years ]
    Development of AKI (KDIGO definition)

  12. Number of participants who experience acute kidney injury (AKI) [ Time Frame: 10 years ]
    Development of AKI (KDIGO definition)

  13. Number of participants who experience acute kidney injury (AKI) [ Time Frame: 15 years ]
    Development of AKI (KDIGO definition)

  14. Number of participants admitted to hospital with a new diagnosis of cardiac failure [ Time Frame: 5 years ]
    Number of participants admitted to hospital with a new diagnosis of cardiac failure

  15. Number of participants admitted to hospital with a new diagnosis of cardiac failure [ Time Frame: 10 years ]
    Number of participants admitted to hospital with a new diagnosis of cardiac failure

  16. Number of participants admitted to hospital with a new diagnosis of cardiac failure [ Time Frame: 15 years ]
    Number of participants admitted to hospital with a new diagnosis of cardiac failure

  17. Number of participants with an unplanned hospital admission [ Time Frame: 5 years ]
    Number of participants with an unplanned hospital admission

  18. Number of participants with an unplanned hospital admission [ Time Frame: 10 years ]
    Number of participants with an unplanned hospital admission

  19. Number of participants with an unplanned hospital admission [ Time Frame: 15 years ]
    Number of participants with an unplanned hospital admission

  20. Number of participants admitted to hospital with an infection [ Time Frame: 5 years ]
    Number of participants admitted to hospital with an infection

  21. Number of participants admitted to hospital with an infection [ Time Frame: 10 years ]
    Number of participants admitted to hospital with an infection

  22. Number of participants admitted to hospital with an infection [ Time Frame: 15 years ]
    Number of participants admitted to hospital with an infection

  23. Number of participants with a new diagnosis of cancer [ Time Frame: 5 years ]
    Number of participants with a new diagnosis of cancer

  24. Number of participants with a new diagnosis of cancer [ Time Frame: 10 years ]
    Number of participants with a new diagnosis of cancer

  25. Number of participants with a new diagnosis of cancer [ Time Frame: 15 years ]
    Number of participants with a new diagnosis of cancer

  26. Number of participants with a hip fracture [ Time Frame: 5 years ]
    Number of participants with a hip fracture

  27. Number of participants with a hip fracture [ Time Frame: 10 years ]
    Number of participants with a hip fracture

  28. Number of participants with a hip fracture [ Time Frame: 15 years ]
    Number of participants with a hip fracture

  29. Number of participants with progression of chronic kidney disease (CKD) (KDIGO definition) [ Time Frame: 5 years ]
    Progression of CKD (KDIGO definition:25% reduction in GFR and progression to next CKD category)

  30. Number of participants with progression of chronic kidney disease (CKD) (KDIGO definition) [ Time Frame: 10 years ]
    Progression of CKD (KDIGO definition:25% reduction in GFR and progression to next CKD category)

  31. Number of participants with progression of chronic kidney disease (CKD) (KDIGO definition) [ Time Frame: 15 years ]
    Progression of CKD (KDIGO definition:25% reduction in GFR and progression to next CKD category)


Biospecimen Retention:   Samples With DNA
Plasma, serum, urine, DNA, renal biopsy tissue


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.

Criteria

Participants with CKD

Inclusion Criteria:

  1. Age Over 18 years of age
  2. Estimated GFR 59-15ml/min/1.73m² or eGFR >60ml/min/1.73m² and urine albumin to creatinine ratio >30mg/mmol
  3. Seen at least once in a Nephrology Clinic
  4. Willing to participate in two study visits
  5. Able to give informed consent and participate in study procedures

Exclusion Criteria:

  1. Recipient of a solid organ transplant
  2. Expected survival less than 1 year (in the opinion of local investigators)
  3. Acute kidney injury within 3 months of recruitment
  4. Major Acute Cardiovascular Event (MACE) within 3 months of recruitment

Participants without CKD - controls Inclusion criteria

  1. Age over 18 years of age
  2. Willing to participate in one study visit
  3. Able to give informed consent and participate in study procedures
  4. No evidence of CKD
  5. No other major illnesses except for hypertension and type 2 diabetes mellitus (50 participants will have diabetes but no CKD)

Exclusion criteria

  1. Estimated GFR<60ml/min/1.73m2 in previous 12 months or last available result
  2. Urine albumin to creatinine ratio >3mg/mmol in previous 12 months or last available result
  3. Previous unilateral nephrectomy or partial nephrectomy
  4. Recipient of a solid organ transplant
  5. Expected survival less than 1 year (in the opinion of local investigators)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084145


Contacts
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Contact: Fiona Robertson 01332 724636 fiona.robertson@nottingham.ac.uk

Locations
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United Kingdom
Royal Derby Hospital Recruiting
Derby, Derbyshire, United Kingdom, DE22 £NE
Contact: Maarten Taal       maarten.taal1@nhs.net   
Contact: kelly White       kelly.white@nhs.net   
Salford Royal Hospital Recruiting
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
University of Nottingham
Kidney Cancer UK
UK Renal Registry
University of Bristol
University of Birmingham
University of Southampton
University of Geneva, Switzerland
NIHR National Biosample Centre
UCB Pharma Ltd
Evotec International GmbH
AbbVie
Investigators
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Principal Investigator: Maarten Taal University of Nottingham
  Study Documents (Full-Text)

Documents provided by University of Nottingham:
Study Protocol  [PDF] February 28, 2019


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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT04084145     History of Changes
Other Study ID Numbers: 16091
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Application for use of data to an independent strategic oversight and access committee (SOAC)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: variable depending on applications
Access Criteria: Approval of application by independent SOAC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency