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Active, Not Recruiting

NCT Number: NCT01722383

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2WB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants not alive

    Time frame: up to 10 years

Secondary outcomes

  1. 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

Other outcomes

  1. Number of participants who sustain one or more cardiovascular events

    Time frame: up to 10 years

  2. Number of patients who require hospitalisation

    Time frame: up to 10 years

  3. Number of patients who sustain a decline of kidney function

    Time frame: up to 10 years

    As measured by estimated glomerular filtration rate

Sponsors and collaborators

Lead sponsor

University Hospital Birmingham NHS Foundation Trust

Other

Registry information

Acronym: RIISC

Important dates

Study start
2010
Primary completion
2025
Study completion
2026
First posted
Nov 6, 2012
Registry last updated
Oct 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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