Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
IMPLICATE
1 other identifier
interventional
242
1 country
1
Brief Summary
This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedAugust 16, 2019
September 1, 2009
10.2 years
June 26, 2009
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary (composite): death, and hospitalisation
death and emergency hospitalisation during the following 2 years afterr andomisation
24 months after enrollment
Secondary Outcomes (1)
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
24 months after enrollment
Study Arms (2)
nephrologists
ACTIVE COMPARATORCombined management PCP: nephrologists (at least 4 nephrology visits/year)
Primary Care Physicians
ACTIVE COMPARATORManagement by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
Interventions
* Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management. * Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.
Eligibility Criteria
You may qualify if:
- Patients with CKD stage 3, 4 and 5 (CCl \< 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.
You may not qualify if:
- Patients previously known by nephrologists.
- Estimated life expectancy \< 1 year
- Refusal or inability to sign writing consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Patrick Saudanlead
- Schweizerische Nierenligacollaborator
Study Sites (1)
Nephrology Unit Geneva University Hospitals
Geneva, Geneva City, Switzerland
Related Publications (1)
Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.
PMID: 32272886DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2009
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
August 16, 2019
Record last verified: 2009-09