SOP's for CKD-MBD-Biomarkers

NCT ID: NCT02708368

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2017-12-01

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.

Conditions

Chronic Kidney Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients on dialysis

16 patients on dialysis with a sex ratio 1:1; 8 patients on hemodialysis and 8 patients on hemodiafiltration

blood withdrawal

Intervention Type: OTHER

3 times

Healthy Subjects

16 healthy subjects with a sex ratio 1:1

blood withdrawal

Intervention Type: OTHER

3 times

Interventions

blood withdrawal

3 times

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Clinic for Nephrology and Diabetology, Hospital St. Franziskus (Maria-Hilf-Clinic)

Mönchengladbach, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

15-109

Identifier Type: -

Identifier Source: org_study_id