Skip to main content
OpenTrials
Completed

NCT Number: NCT00929760

Impact of Specialised Renal Care in Patients With Chronic Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Death Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Unit Geneva University Hospitals

Geneva, Geneva City, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

specialised renal care

Behavioral
  • 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 outcomes

  1. Primary (composite): death, and hospitalisation

    Time frame: 24 months after enrollment

    death and emergency hospitalisation during the following 2 years afterr andomisation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Patrick Saudan

Other

Collaborators

  • Schweizerische Nierenliga

Registry information

Official study title

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

Acronym: IMPLICATE

Important dates

Study start
2009
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2009
Registry last updated
Aug 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.