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

August 13, 2019 updated by: Patrick Saudan

Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Geneva City
      • Geneva, Geneva City, Switzerland
        • Nephrology Unit Geneva University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary (composite): death, and hospitalisation
Time Frame: 24 months after enrollment
death and emergency hospitalisation during the following 2 years afterr andomisation
24 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Patrick Saudan

Collaborators

Schweizerische Nierenliga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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