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

NCT01722383 | Active Not Recruiting

• 1 other identifier: RRK3917
• Study Type: observational
• Target: 932
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Number of participants not alive

  up to 10 years

Secondary Outcomes (1)

• Number of participants who reach End Stage Kidney Disease

  up to 10 years

Other Outcomes (3)

• Number of participants who sustain one or more cardiovascular events

  up to 10 years

• Number of patients who require hospitalisation

  up to 10 years

• Number of patients who sustain a decline of kidney function

  up to 10 years

Study Arms (1)

Chronic kidney disease

Stages 3-5 chronic kidney disease (pre-dialysis)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care kidney disease clinics

You may qualify if:

• 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)

You may not qualify if:

• renal replacement therapy
• immunosuppression

Sponsors & Collaborators

• University Hospital Birmingham NHS Foundation Trust: lead

Study Sites (1)

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2WB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33368493 DERIVED

• 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.

  PMID: 24738870 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Urine, DNA, Saliva, Dental Plaque

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Cockwell, MB BCh

  University Hospital Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: October 1, 2010
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 5, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)