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Impact of Specialised Renal Care in Patients With Chronic Kidney Disease (IMPLICATE)

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ClinicalTrials.gov Identifier: NCT00929760
Recruitment Status : Completed
First Posted : June 29, 2009
Last Update Posted : August 16, 2019
Sponsor:
Collaborator:
Schweizerische Nierenliga
Information provided by (Responsible Party):
Patrick Saudan, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE June 26, 2009
First Posted Date  ICMJE June 29, 2009
Last Update Posted Date August 16, 2019
Study Start Date  ICMJE June 2009
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
Primary (composite): death, and hospitalisation [ Time Frame: 24 months after enrollment ]
death and emergency hospitalisation during the following 2 years afterr andomisation
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Primary (composite): death, and hospitalisation [ Time Frame: 24 months after enrollment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life [ Time Frame: 24 months after enrollment ]
cf title
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life [ Time Frame: 24 months after enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
Official Title  ICMJE Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Behavioral: specialised renal care
  • 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.
Study Arms  ICMJE
  • Active Comparator: nephrologists
    Combined management PCP: nephrologists (at least 4 nephrology visits/year)
    Intervention: Behavioral: specialised renal care
  • Active Comparator: Primary Care Physicians
    Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
    Intervention: Behavioral: specialised renal care
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
242
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2009)
400
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients previously known by nephrologists.
  • Estimated life expectancy < 1 year
  • Refusal or inability to sign writing consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929760
Other Study ID Numbers  ICMJE 08-226
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Saudan, University Hospital, Geneva
Study Sponsor  ICMJE Patrick Saudan
Collaborators  ICMJE Schweizerische Nierenliga
Investigators  ICMJE Not Provided
PRS Account University Hospital, Geneva
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP