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

Chronic Kidney Disease Clinical Trial

— RIISC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01722383
• Other study ID #: RRK3917
• Status: Active, not recruiting
• Phase: N/A
• First received: November 2, 2012
• Last updated: October 4, 2016
• Start date: October 2010
• Est. completion date: December 2026

Study information

• Verified date: October 2016
• Source: University Hospital Birmingham NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 932
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Birmingham NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who sustain one or more cardiovascular events		up to 10 years	No
Other	Number of patients who require hospitalisation		up to 10 years	No
Other	Number of patients who sustain a decline of kidney function	As measured by estimated glomerular filtration rate	up to 10 years	No
Primary	Number of participants not alive		up to 10 years	No
Secondary	Number of participants who reach End Stage Kidney Disease	End Stage Kidney Disease describes a requirement for chronic dialysis treatment or a kidney transplant	up to 10 years	No