Chronic Kidney DiseaseIMPLICATENCT00929760
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
A study testing specialised renal care in people with Chronic Kidney Disease, run by Patrick Saudan at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- specialised renal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients previously known by nephrologists.
- Estimated life expectancy < 1 year
- Refusal or inability to sign writing consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nephrology Unit Geneva University Hospitals
Geneva, Geneva City
About this study
Official title: 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- specialised renal care
- Keywords
- Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care
- Medical subject headings
- Renal Insufficiency, Chronic, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specialised renal careBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| nephrologists | Active comparator | Combined management PCP: nephrologists (at least 4 nephrology visits/year) Receives: Behavioral: specialised renal care |
| Primary Care Physicians | Active comparator | Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG Receives: Behavioral: specialised renal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (composite): death, and hospitalisation
death and emergency hospitalisation during the following 2 years afterr andomisation
Measured: 24 months after enrollment
Secondary outcomes (1)
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
cf title
Measured: 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patrick Saudan
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerische Nierenliga
- Responsible party
- Sponsor-investigator, Patrick Saudan, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929760
- Sponsor's protocol ID
- 08-226
- Acronym
- IMPLICATE
- Status last verified
- Sep 2009
- First submitted
- 26 Jun 2009
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.
PubMed 32272886
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"
- ClinicalTrials.gov ID
- NCT00929760
- Acronym / sponsor ID
- IMPLICATE / 08-226
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney disease, Nephrologists, Primary Care, Death, Renal Replacement Therapy, Specialised renal care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Patrick SaudanUniversity, hospital or other
- Collaborators
- Schweizerische Nierenliga
- Study start
- Jun 2009
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 29 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nephrologists | Active comparator | Behavioral: specialised renal careCombined management PCP: nephrologists (at least 4 nephrology visits/year) |
| Primary Care Physicians | Active comparator | Behavioral: specialised renal careManagement by PCPs only, with the help of written instructions from our nephrology unit based on EBPG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients previously known by nephrologists.
- Estimated life expectancy < 1 year
- Refusal or inability to sign writing consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Primary Care Physicians, nephrologists |
Primary outcome
Primary (composite): death, and hospitalisation
Time frame: 24 months after enrollment
death and emergency hospitalisation during the following 2 years afterr andomisation
1 secondary outcome
Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life
Time frame: 24 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 32272886Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing specialised renal care in people with Chronic Kidney Disease, run by Patrick Saudan at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (composite): death, and hospitalisation (time frame: 24 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.