- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02708368
SOP's for CKD-MBD-Biomarkers
Investigation to Develop Standard Operating Procedures (SOP) for the Determination of Innovative CKD-MBD(Chronic Kidney Disease - Mineral Bone Disorder)-Serum-(Plasma-)Parameters
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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NRW
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Aachen, NRW, Germany, 52074
- Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
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Mönchengladbach, NRW, Germany, 41063
- Clinic for Nephrology and Diabetology, Hospital St. Franziskus (Maria-Hilf-Clinic)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients on dialysis
16 patients on dialysis with a sex ratio 1:1; 8 patients on hemodialysis and 8 patients on hemodiafiltration
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3 times
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Healthy Subjects
16 healthy subjects with a sex ratio 1:1
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3 times
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
an optimal analysis of innovative CKD-MBD-Biomarkers
Time Frame: through study completion, an average of 3 months
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through study completion, an average of 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Renal Insufficiency
- Nutrition Disorders
- Musculoskeletal Diseases
- Parathyroid Diseases
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Bone Diseases
- Bone Diseases, Metabolic
- Calcium Metabolism Disorders
- Rickets
- Vitamin D Deficiency
- Hyperparathyroidism, Secondary
- Hyperparathyroidism
- Kidney Diseases
- Renal Insufficiency, Chronic
- Chronic Kidney Disease-Mineral and Bone Disorder
Other Study ID Numbers
- 15-109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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