NCT02229435

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,031,336

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
Last Updated

September 1, 2014

Status Verified

August 1, 2014

Enrollment Period

9.7 years

First QC Date

August 26, 2014

Last Update Submit

August 28, 2014

Conditions

Chronic Kidney Disease (CKD)

Keywords

Chronic kidney diseaseUrological careNephrological care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • dialysis
  • no serum creatinine measured
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Urology University Magdeburg

Magdeburg, Saxony-Anhalt, 39108, Germany

Location

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 1, 2014

Study Start

December 1, 2004

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 1, 2014

Record last verified: 2014-08

Locations

DE(1)