ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00929760
Recruitment Status : Unknown
Verified September 2009 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : June 29, 2009
Last Update Posted : September 16, 2009
Sponsor:
Collaborator:
Schweizerische Nierenliga
Information provided by:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

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 ]

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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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


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

Responsible Party: Dr Patrick Saudan, Nephrology Unit
ClinicalTrials.gov Identifier: NCT00929760     History of Changes
Other Study ID Numbers: 08-226
First Posted: June 29, 2009    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009

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
Urologic Diseases
Renal Insufficiency