SOP's for CKD-MBD-Biomarkers

NCT02708368 | Completed

• 1 other identifier: 15-109
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 2

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

Keywords

Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)

Outcome Measures

Primary Outcomes (1)

• an optimal analysis of innovative CKD-MBD-Biomarkers

  through study completion, an average of 3 months

Study Arms (2)

Patients on dialysis

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

Other: blood withdrawal

Healthy Subjects

16 healthy subjects with a sex ratio 1:1

Other: blood withdrawal

Interventions

blood withdrawal OTHER

3 times

Healthy Subjects; Patients on dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (2)

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

Aachen, North Rhine-Westphalia, 52074, Germany

Location

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

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 15, 2016
• Study Start: June 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2017
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)