Clinical trial NCT02708368: SOP's for CKD-MBD-Biomarkers
Official title: Investigation to Develop Standard Operating Procedures (SOP) for the Determination of Innovative CKD-MBD(Chronic Kidney Disease - Mineral Bone Disorder)-Serum-(Plasma-)Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are regularly on dialysis in the clinics will be selected . Healthy Subjects will be recruited over notices in clinic.

Brief summary: CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease.

During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.


Eligibility criteria: Inclusion Criteria:

* Patients who are regularly (3 times a week) on dialysis in the Maria-Hilf-Clinic or healthy subjects
* Male or Female at the age of at least 18 years
* Patients who will be admitted to the clinics of the University Hospital RWTH Aachen or of the Maria-Hilf-Clinic Mönchengladbach or healthy subjects
* written informed consent form
* Subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel

Exclusion Criteria:

* age \< 18 years
* subjects who are unwilling or not able to consent
* pregnant or lactating women
* subject has been committed to an institution by legal or regulatory order
* dependency or working relationship with the investigator
* participation in a parallel interventional clinical study
* Hb-value \< 10 g/dl

Primary outcomes:
measure: an optimal analysis of innovative CKD-MBD-Biomarkers
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
state: NRW
city: Mönchengladbach
country: Germany
facility: Clinic for Nephrology and Diabetology, Hospital St. Franziskus (Maria-Hilf-Clinic)
state: NRW
Study officials:
References: