SOP's for CKD-MBD-Biomarkers

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708368
• Other study ID #: 15-109
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 1, 2017
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease-Mineral and Bone Disorder
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• blood withdrawal
3 times

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen	Aachen	NRW
Germany	Clinic for Nephrology and Diabetology, Hospital St. Franziskus (Maria-Hilf-Clinic)	Mönchengladbach	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	an optimal analysis of innovative CKD-MBD-Biomarkers		through study completion, an average of 3 months