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

NCT ID: NCT01722383

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

932 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic kidney disease

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Paul Cockwell

Consultant Nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Cockwell, MB BCh

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham

Locations

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Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 33368493 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24738870 (View on PubMed)

Other Identifiers

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RRK3917

Identifier Type: -

Identifier Source: org_study_id

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