Clinical trial NCT01722383: What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study
Official title: What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2012-11-06
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care kidney disease clinics

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* renal replacement therapy
* immunosuppression

Primary outcomes:
measure: Number of participants not alive
timeFrame: up to 10 years
Secondary outcomes:
measure: Number of participants who reach End Stage Kidney Disease
timeFrame: up to 10 years
Other outcomes:
measure: Number of participants who sustain one or more cardiovascular events
timeFrame: up to 10 years
measure: Number of patients who require hospitalisation
timeFrame: up to 10 years
measure: Number of patients who sustain a decline of kidney function
timeFrame: up to 10 years
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
state: West Midlands
Study officials:
affiliation: University Hospital Birmingham
name: Paul Cockwell, MB BCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sharma 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.