Chronic Kidney DiseaseRIISCNCT01722383
What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study
An observational study of Chronic Kidney Disease, run by University Hospital Birmingham NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with significant morbidity and mortality. People at highest risk from progressive CKD are defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of significant albuminuria/proteinuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 932 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Secondary care kidney disease clinics
Who may be able to join
- Decline of eGFR of ≥5mls/min/year or ≥10mls/min/5years
- and/or urinary albumin-creatinine ration (ACR) ≥70 mg/mmol on three occasions
- and/or CKD 4 or 5 (pre-dialysis)
Who cannot join
- renal replacement therapy
- immunosuppression
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2WB
About this study
Chronic kidney disease (CKD) affects up to 16% of the adult population and is associated with significant morbidity and mortality. People at highest risk from progressive CKD are defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of this group will enable improved risk stratification and direct the development of better targeted management for people with CKD. To address these requirements we have established the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent follow-up.
- Conditions
- Chronic Kidney Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Stages 3-5 chronic kidney disease (pre-dialysis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants not alive
Measured: up to 10 years
Secondary outcomes (1)
Number of participants who reach End Stage Kidney Disease
End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 932 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Cockwell, University Hospital Birmingham NHS Foundation Trust
- Investigators
- Paul Cockwell, MB BCh, Principal investigator, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722383
- Sponsor's protocol ID
- RRK3917
- Acronym
- RIISC
- Status last verified
- Oct 2016
- First submitted
- 2 Nov 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymised patient data is being shared within the remit of the ethics for this study with collaborators
Publications
Sharma P, Fenton A, Dias IHK, Heaton B, Brown CLR, Sidhu A, Rahman M, Griffiths HR, Cockwell P, Ferro CJ, Chapple IL, Dietrich T. Oxidative stress links periodontal inflammation and renal function. J Clin Periodontol. 2021 Mar;48(3):357-367. doi: 10.1111/jcpe.13414. Epub 2021 Jan 28.
PubMed 33368493Sharma P, Dietrich T, Sidhu A, Vithlani V, Rahman M, Stringer S, Jesky M, Kaur O, Ferro C, Cockwell P, Chapple IL. The periodontal health component of the Renal Impairment In Secondary Care (RIISC) cohort study: a description of the rationale, methodology and initial baseline results. J Clin Periodontol. 2014 Jul;41(7):653-61. doi: 10.1111/jcpe.12263. Epub 2014 May 14.
PubMed 24738870
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study
- ClinicalTrials.gov ID
- NCT01722383
- Acronym / sponsor ID
- RIISC / RRK3917
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 932 participants (actual)
- Lead sponsor
- University Hospital Birmingham NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Not posted in the source record
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) affects up to 16% of the adult population and is associated with significant morbidity and mortality. People at highest risk from progressive CKD are defined by a sustained decline in estimated glomerular filtration rate (eGFR) and/or the presence of significant albuminuria/proteinuria. Accurate mapping of the bio-clinical determinants of this group will enable improved risk stratification and direct the development of better targeted management for people with CKD. To address these requirements we have established the Renal Impairment in Secondary Care (RIISC) study; RIISC is enrolling a cohort of patients at high risk from progressive CKD and compiling a comprehensive and detailed bio-clinical phenotype, including vascular and oral health phenotyping, at enrolment and on subsequent follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | –Stages 3-5 chronic kidney disease (pre-dialysis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary care kidney disease clinics
Key inclusion criteria (3 listed)
- Decline of eGFR of ≥5mls/min/year or ≥10mls/min/5years
- and/or urinary albumin-creatinine ration (ACR) ≥70 mg/mmol on three occasions
- and/or CKD 4 or 5 (pre-dialysis)
Key exclusion criteria (2 listed)
- renal replacement therapy
- immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants not alive
Time frame: up to 10 years
1 secondary outcome
Number of participants who reach End Stage Kidney Disease
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 33368493Sharma P, Fenton A, Dias IHK, Heaton B, Brown CLR, Sidhu A, Rahman M, Griffiths HR, Cockwell P, Ferro CJ, Chapple IL, Dietrich T. Oxidative stress links periodontal inflammation and renal function. J Clin Periodontol. 2021 Mar;48(3):357-367. doi: 10.1111/jcpe.13414. Epub 2021 Jan 28.
- Derived from this study: PubMed 24738870Sharma P, Dietrich T, Sidhu A, Vithlani V, Rahman M, Stringer S, Jesky M, Kaur O, Ferro C, Cockwell P, Chapple IL. The periodontal health component of the Renal Impairment In Secondary Care (RIISC) cohort study: a description of the rationale, methodology and initial baseline results. J Clin Periodontol. 2014 Jul;41(7):653-61. doi: 10.1111/jcpe.12263. Epub 2014 May 14.
- Individual participant dataSharing planned: Yes. Anonymised patient data is being shared within the remit of the ethics for this study with collaborators
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Paul Cockwell, MB BCh principal investigator
University Hospital Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University Hospital Birmingham NHS Foundation Trust at 1 site 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants not alive (time frame: up to 10 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 NCT01722383, which also lists 2 linked publications.
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 5 Oct 2016.