Chronic Kidney Disease (CKD)UroCKDisSNCT02229435
Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.
An observational study of Chronic Kidney Disease (CKD), run by University of Magdeburg at 1 site in Germany.
Trial summary
Statement: Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo nephrological and urological care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- How many people
- 1,031,336 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2004to Aug 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All sampled outpatient patients (blood tests with measurement of serum creatinine) 12/2004-08/2014 of the medical laboratory Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, metroplitan area Magdeburg Saxony-Anhalt, Germany.
Who may be able to join
- Measured serum creatinine and estimated glomerular filtration rate
- eGFR < 60 ml/min
Who cannot join
- dialysis
- no serum creatinine measured
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Urology University Magdeburg
Magdeburg, Saxony-Anhalt, 39108
About this study
Official title: Laboratory Database-based Analysis of the Interdisciplinary Urologic-nephrological Care of the Chronic Kidney Disease (CKD) With Estimated Glomerular Filtration Rate (eGFR) Under 60 ml/Min of the Population in Saxony-Anhalt / Metropolitan Area Magdeburg.
Statement:
Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo nephrological and urological care (diagnosis and treatment) to prevent chronic kidney failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD. Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD should be treated and the medical care should be optimized.
Read more
Hypothesis:
Not all patients with CKD receive urological and nephrological care. Interdisciplinary work of outpatient working urologists and nephrologists in the metropolitan area Magdeburg / Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment connection of CKD patients for an orientating statement is needed.
Read the detailed description
The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood samples of outpatient patients of the medical practices of the metropolitan area Magdeburg Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the submitting practice. Every submitting medical doctor has a lifetime identification number and is identified by her/his medical subject /specialization. This analysis is based on that laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is evaluated, that had been received blood tests with measurement of serum creatinine. For every serum creatinine an eGGR is calculated with the guideline recommended formula.
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Chronic kidney disease, Urological care, Nephrological care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| eGFR <60ml/min | Patients with CKD with eGFR <60 ml/min (CKD-EPI or MDRD) 12/2004-08/2014 of Medical Laboratory, Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, Germany. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic kidney disease
% of outpatient patients with eGFR < 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study startDec 2004
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies 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
- Observational
- Observational model
- Cohort
- Enrolment
- 1,031,336 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Laboratory Schenk-Ansorge Magdeburg Germany.
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Johann J Wendler, Dr., Principal investigator, Urology University MagdeburgMartin Schostak, Prof. Dr., Study chair, Urology University MagdeburgHerwart Schenk, Prof. Dr., Study director, Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.Constanze Tienken, Cand. med., Principal investigator, Doctorand Urology University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229435
- Sponsor's protocol ID
- URO-MD-040
- Acronym
- UroCKDisS
- Status last verified
- Aug 2014
- First submitted
- 26 Aug 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Database-based Analysis of the Interdisciplinary Urologic-nephrological Care of the Chronic Kidney Disease (CKD) With Estimated Glomerular Filtration Rate (eGFR) Under 60 ml/Min of the Population in Saxony-Anhalt / Metropolitan Area Magdeburg.
- ClinicalTrials.gov ID
- NCT02229435
- Acronym / sponsor ID
- UroCKDisS / URO-MD-040
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Chronic kidney disease, Urological care, Nephrological care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,031,336 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Collaborators
- Medical Laboratory Schenk-Ansorge Magdeburg Germany.
- Study start
- Dec 2004
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Sep 2014 (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.
Statement:
Patients with Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) under 60 ml/min using the MDRD-6 (Modification of Diet in Renal Disease) formula and/or CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula should undergo nephrological and urological care (diagnosis and treatment) to prevent chronic kidney failure. This is recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI), Kidney Disease Improving Global Outcomes (KDIGO) and European Urological Association (EAU). Renal and postrenal diseases can cause or worsen CKD. Internistic and intrarenal diseases can caused or worsen CKD. All diseases affecting CKD should be treated and the medical care should be optimized.
Hypothesis:
Not all patients with CKD receive urological and nephrological care. Interdisciplinary work of outpatient working urologists and nephrologists in the metropolitan area Magdeburg / Saxony-Anhalt Germany is unknown. An descriptive analysis of interdisciplinary treatment connection of CKD patients for an orientating statement is needed.
Detailed description
The Medical Laboratory Schenk-Ansorge Magdeburg Saxony-Anhalt Germany receives all blood samples of outpatient patients of the medical practices of the metropolitan area Magdeburg Saxony-Anhalt Germany. Every patient has a lifetime identification number Independent of the submitting practice. Every submitting medical doctor has a lifetime identification number and is identified by her/his medical subject /specialization. This analysis is based on that laboratory database. For that study a cohort of 1.031.336 patients from 12/2004 to 08/2014 is evaluated, that had been received blood tests with measurement of serum creatinine. For every serum creatinine an eGGR is calculated with the guideline recommended formula.
Study design
- Observational model
- Cohort
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eGFR <60ml/min | – | –Patients with CKD with eGFR <60 ml/min (CKD-EPI or MDRD) 12/2004-08/2014 of Medical Laboratory, Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, Germany. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All sampled outpatient patients (blood tests with measurement of serum creatinine) 12/2004-08/2014 of the medical laboratory Prof. Schenk / Dr. Ansorge and Colleagues, GbR, Am Neustädter Feld 47, 39124 Magdeburg, metroplitan area Magdeburg Saxony-Anhalt, Germany.
Key inclusion criteria (2 listed)
- Measured serum creatinine and estimated glomerular filtration rate
- eGFR < 60 ml/min
Key exclusion criteria (3 listed)
- dialysis
- no serum creatinine measured
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic kidney disease
Time frame: 1 year
% of outpatient patients with eGFR < 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany.
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 1 Sep 2014.
- Medical Laboratory Schenk-Ansorge Magdeburg, Germany.Link provided by the sponsor.
- Department of Urology University Magdeburg, Germany.Link provided by the sponsor.
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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.
Johann J Wendler, Dr. principal investigator
Urology University Magdeburg
Martin Schostak, Prof. Dr. study chair
Urology University Magdeburg
Herwart Schenk, Prof. Dr. study director
Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by University of Magdeburg at 1 site in Germany.
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 2 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 1 Sep 2014. 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 Germany. 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?
Chronic kidney disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.