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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schweizerische Nierenliga
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00929760
First received: June 26, 2009
Last updated: September 15, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention
Chronic Kidney Disease
 Behavioral: specialised renal care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Primary (composite): death, and hospitalisation [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life [ Time Frame: 24 months after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2009
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929760

Contacts
Contact: Patrick Saudan, MD 41223729764 Patrick.Saudan@hcuge.ch

Locations
Switzerland
Nephrology Unit Geneva University Hospitals Recruiting
Geneva, Geneva city, Switzerland
Principal Investigator: Patrick Saudan, MD            
Sub-Investigator: Nicola Marangon, MD            
Sponsors and Collaborators
University Hospital, Geneva
Schweizerische Nierenliga
  More Information

No publications provided

Responsible Party: Dr Patrick Saudan, Nephrology Unit
ClinicalTrials.gov Identifier: NCT00929760     History of Changes
Other Study ID Numbers: 08-226
Study First Received: June 26, 2009
Last Updated: September 15, 2009
Health Authority: Switzerland: Ethikkommission
Switzerland:Hôpitaux Universitaires de Genève

Keywords provided by University Hospital, Geneva:
Chronic Kidney disease
Nephrologists
Primary Care
 Death
Renal Replacement Therapy
Specialised renal care

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013