What Are the Determinations of Adult Progressive CKD? The Renal Impairment In Secondary Care (RIISC) Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01722383

Acronym

RIISC

Enrollment

932

Registered

2012-11-06

Start date

2010-10-31

Completion date

2026-12-31

Last updated

2016-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants not alive	up to 10 years

Secondary

Measure	Time frame	Description
Number of participants who reach End Stage Kidney Disease	up to 10 years	End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant

Other

Measure	Time frame	Description
Number of patients who sustain a decline of kidney function	up to 10 years	As measured by estimated glomerular filtration rate
Number of participants who sustain one or more cardiovascular events	up to 10 years	—
Number of patients who require hospitalisation	up to 10 years	—

Countries

United Kingdom

Outcome results