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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

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: specialised renal care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
Study Start Date : June 2009
Actual Primary Completion Date : August 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: nephrologists
Combined management PCP: nephrologists (at least 4 nephrology visits/year)
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.

Active Comparator: Primary Care Physicians
Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG
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.




Primary Outcome Measures :
  1. Primary (composite): death, and hospitalisation [ Time Frame: 24 months after enrollment ]
    death and emergency hospitalisation during the following 2 years afterr andomisation


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929760


Locations
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Switzerland
Nephrology Unit Geneva University Hospitals
Geneva, Geneva City, Switzerland
Sponsors and Collaborators
Patrick Saudan
Schweizerische Nierenliga

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Responsible Party: Patrick Saudan, Professor, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00929760    
Other Study ID Numbers: 08-226
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: September 2009
Keywords provided by Patrick Saudan, University Hospital, Geneva:
Chronic Kidney disease
Nephrologists
Primary Care
Death
Renal Replacement Therapy
Specialised renal care
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency