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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02229435
Other study ID # URO-MD-040
Secondary ID
Status Completed
Phase N/A
First received August 26, 2014
Last updated August 28, 2014
Start date December 2004
Est. completion date August 2014

Study information

Verified date August 2014
Source University of Magdeburg
Contact n/a
Is FDA regulated No
Health authority Germany: national accreditation body for the Federal Republic of Germany (DAkkS, AkkStelleG, BDI; Federal Association)http://www.dakks.de/en
Study type Observational [Patient Registry]

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1031336
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Measured serum creatinine and estimated glomerular filtration rate

- eGFR < 60 ml/min

Exclusion Criteria:

- dialysis

- no serum creatinine measured

- Age < 18 years

Study Design

Observational Model: Cohort


Locations

Country Name City State
Germany Department of Urology University Magdeburg Magdeburg Saxony-Anhalt

Sponsors (2)

Lead Sponsor Collaborator
University of Magdeburg Medical Laboratory Schenk-Ansorge Magdeburg Germany.

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chronic kidney disease % of outpatient patients with eGFR < 60 ml/min and interdisciplinary urological and nephrological care in metropolitan area Magdeburg, Saxony-Anhalt, Germany. 1 year No
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