Urologic-nephrological Care of Chronic Kidney Disease in... | NCT02229435

Studies
Urologic-nephrological Care of Chronic Kidney Disease in Saxony-Anhalt/Magdeburg.

NCT02229435

Sponsor

University of Magdeburg

Status

Completed

Last Update Posted

Sep 1, 2014Estimated

Enrollment

1,031,336Actual

Phase

Not provided

Conditions

Chronic Kidney Disease (CKD)

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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.

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Aug 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 26, 2014

First Submission Date that Met QC Criteria

Aug 28, 2014

First Posted Date

Sep 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2014

Last Update Posted Date

Sep 1, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Johann J. Wendler, MD, Dr. med., University of MagdeburgPrincipal Investigator

Lead Sponsor

University of MagdeburgOTHER

Collaborators

Name	Class
Medical Laboratory Schenk-Ansorge Magdeburg Germany.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,031,336Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Measured serum creatinine and estimated glomerular filtration rate
eGFR < 60 ml/min

Exclusion Criteria:

dialysis
no serum creatinine measured
Age < 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Johann J Wendler, Dr.	Urology University Magdeburg	Principal Investigator
Martin Schostak, Prof. Dr.	Urology University Magdeburg	Study Chair
Herwart Schenk, Prof. Dr.	Medical Laboratory Am Neustädter Feld 47, 39124 Magdeburg, Saxony-Anhalt, Germany.	Study Director
Constanze Tienken, Cand. med.	Doctorand Urology University Magdeburg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology University Magdeburg		Magdeburg	Saxony-Anhalt	39108	Germany

References Module

Citations

Not provided

Label	URL
Medical Laboratory Schenk-Ansorge Magdeburg, Germany.	View source
Department of Urology University Magdeburg, Germany.	View source

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases