Chronic Kidney DiseaseNCT01688141
A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
A study testing Enhanced management in people with Chronic Kidney Disease, run by University Hospitals, Leicester at 3 sites in United Kingdom.
Trial summary
Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Enhanced management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28,304 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2010to 11 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- measurement of serum creatinine
- eGFR < 60 ml/min/1.73m2
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Leicester General Hospital
Leicester, Leics, LE5 4PW
University Hospitals Leicester
Leicester, Leics, LE5 4PW
University Hospitals of Leicester
Leicester
About this study
Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers.
The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials.
Read more
The aims of the study are:
- To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes.
- To foster excellence in CKD care
- To improve coding of CKD and prevalence on chronic disease registers.
- To increase interest in, and capacity for primary care research in Northamptonshire.
- To implement and evaluate a new model of partnership working between primary and secondary care.
The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.
Read the detailed description
see above
- Conditions
- Chronic Kidney Disease
- Being tested
- Enhanced management
- Keywords
- CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced managementOther
Also called CKD management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Enhanced Management | Active comparator | Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. Receives: Other: Enhanced management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Measured: Baseline and 3.5 years
Secondary outcomes (6)
Blood Pressure Control
Observation of blood pressure control over the study period via blood pressure targets
Measured: Baseline and 3.5 years
Proteinuria
Proteinuria coding in practices
Measured: 3.5 years
Incidence of Cardiovascular Events
Observation of incidence of cardiovascular events over the study period
Measured: 3.5 years
Other Biochemical Parameters
Nature and incidence over the study period
Measured: 3.5 years
Referrals to Secondary Care and Hospitalisations
Data coillected from secondary care
Measured: 3.5 years
Mortality
data collected from secondary care
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2014
- Study completion11 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nigel Brunskill, PhD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01688141
- Sponsor's protocol ID
- Shelton
- Status last verified
- Mar 2020
- First submitted
- 20 Nov 2009
- Last updated
- 8 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Major RW, Brown C, Shepherd D, Rogers S, Pickering W, Warwick GL, Barber S, Ashra NB, Morris T, Brunskill NJ. The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care. J Am Soc Nephrol. 2019 Jul;30(7):1261-1270. doi: 10.1681/ASN.2018101042. Epub 2019 May 16.
PubMed 31097609
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01688141
- Acronym / sponsor ID
- Shelton
- Conditions
- Chronic Kidney Disease
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28,304 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Posted 8 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers.
The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials.
The aims of the study are:
- To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes.
- To foster excellence in CKD care
- To improve coding of CKD and prevalence on chronic disease registers.
- To increase interest in, and capacity for primary care research in Northamptonshire.
- To implement and evaluate a new model of partnership working between primary and secondary care.
The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.
Detailed description
see above
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Enhanced Management | Active comparator | Other: Enhanced managementPractices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- measurement of serum creatinine
- eGFR < 60 ml/min/1.73m2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced managementAlso: CKD managementSpecialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care. | Other | Enhanced Management |
Primary outcome
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Time frame: Baseline and 3.5 years
6 secondary outcomes
Blood Pressure Control
Time frame: Baseline and 3.5 years
Proteinuria
Time frame: 3.5 years
Incidence of Cardiovascular Events
Time frame: 3.5 years
Other Biochemical Parameters
Time frame: 3.5 years
Referrals to Secondary Care and Hospitalisations
Time frame: 3.5 years
Mortality
Time frame: 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31097609Major RW, Brown C, Shepherd D, Rogers S, Pickering W, Warwick GL, Barber S, Ashra NB, Morris T, Brunskill NJ. The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care. J Am Soc Nephrol. 2019 Jul;30(7):1261-1270. doi: 10.1681/ASN.2018101042. Epub 2019 May 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Brunskill, PhD principal investigator
Consultant
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced management in people with Chronic Kidney Disease, run by University Hospitals, Leicester at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study (time frame: Baseline and 3.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01688141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.