Diurnal Variation in Markers of Mineral and Bone Disease in Chronic Kidney Disease

NCT03698422 | Completed DMC

• 1 other identifier: H-18037663
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether there are diurnal variations in magnesium and other markers related to mineral metabolism in blood from patients with chronic kidney disease (CKD) compared to healthy controls.

Conditions

Chronic Kidney Diseases; Mineral Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

• Diurnal change in serum magnesium within groups

  change in serum magnesium (mmol/l) within Groups The changes within groups over several timepoints will be compared with linear mixed effect models

  24 hours

Secondary Outcomes (7)

• Change in serum magnesium between groups

  24 hours

• Change in ionized calcium

  24 hours

• Change in p-phosphate

  24 hours

• Change in p-PTH

  24 hours

• Change in p-FGF23

  24 hours

Study Arms (3)

Healthy controls

Estimated glomerular filtration rate (eGFR) \> 60 mL/min for \> 3 months and no known current or chronic medical or surgical conditions. Blood and urine samples are collected for every 3rd hour during 24 hours

Diagnostic Test: Blood and urine samples

Predialysis CKD subjects

Estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for \> 3 months (i.e. CKD stage 4). Blood and urine samples are collected for every 3rd hour during 24 hours

Diagnostic Test: Blood and urine samples

ESKD subjects

Maintenance haemodialysis treatment for \> 3 months for ESKD and with anuria (urine excretion \< 100 mL/day). Blood and urine samples are collected for every 3rd hour during 24 hours

Diagnostic Test: Blood and urine samples

Interventions

Blood and urine samples DIAGNOSTIC_TEST

Subjects will be admitted to the Department of Nephrology, Herlev and Gentofte Hospital, Herlev, Denmark, for 24-hour observation with measurements of serum and urine at three-hour intervals.

ESKD subjects; Healthy controls; Predialysis CKD subjects

Eligibility Criteria

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

Study Population

For healthy controls: estimated glomerular filtration rate (eGFR) \> 60 mL/min for \> 3 months and no known current or chronic medical or surgical conditions. For predialysis CKD subjects: estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for \> 3 months (i.e. CKD stage 4). For ESKD subjects: maintenance haemodialysis treatment for \> 3 months for ESKD and with anuria (urine excretion \< 100 mL/day).

You may qualify if:

• Age ≥ 18 years.
• Serum Mg between 0.7 and 1.1 mmol/L on average of previous measurements over the last 6 months.
• Serum ionised Ca between 1.10 and 1.35 mmol/L on average of previous measurements over the last 6 months.
• Serum phosphate (PO4) between 0.7 and 1.8 mmol/L on average of previous measurements over the last 6 months.
• A negative pregnancy test for women of childbearing age.
• Written informed consent.
• For healthy controls - estimated glomerular filtration rate (eGFR) \> 60 mL/min for \> 3 months and no known current or chronic medical or surgical conditions.
• For predialysis CKD subjects - estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for \> 3 months (i.e. CKD stage 4).
• For ESKD subjects - maintenance haemodialysis treatment for \> 3 months for ESKD and with anuria (urine excretion \< 100 mL/day).

You may not qualify if:

• Diagnosis of diabetes mellitus.
• Kidney transplant recipient.
• Parathyroid hormone (PTH) \> 66 ρmol/L during the previous 3 months.
• Previous parathyroidectomy.
• Current treatment with Mg containing medication or supplements.
• Current treatment with calcimimetics.
• Current treatment with immunosuppressive drugs.
• Active malignant disease.
• Blood haemoglobin \< 6.0 mmol/L
• Any condition impairing Mg absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
• Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma samples are collected

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Specimen Collection

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ditte Hansen, PhD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 9, 2018
• Study Start: October 3, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)