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

October 4, 2016 updated by: Paul Cockwell, University Hospital Birmingham NHS Foundation Trust
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

932

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2WB
        • Queen Elizabeth Hospital Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Secondary care kidney disease clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic kidney disease
Stages 3-5 chronic kidney disease (pre-dialysis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants not alive
Time Frame: up to 10 years
up to 10 years

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Birmingham NHS Foundation Trust

Investigators

  • Principal Investigator: Paul Cockwell, MB BCh, University Hospital Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

November 2, 2012

First Submitted That Met QC Criteria

November 2, 2012

First Posted (Estimate)

November 6, 2012

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRK3917

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymised patient data is being shared within the remit of the ethics for this study with collaborators

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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