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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 May 2015 |
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Main ID: |
NCT02216877 |
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Date of registration:
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12/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
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Scientific title:
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Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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36 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02216877 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Iain B Bressendorff, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Medicine, Division of Nephrology, Roskilde County Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Estimated Glomerular filtration rate (eGFR) < 60 mL/min.
- Serum magnesium < 0.82 mmol/L.
- Written informed consent.
Exclusion Criteria:
- Hemodialysis.
- Peritoneal dialysis.
- Kidney transplant recipient.
- Parathyroid hormone > 600 pg/L.
- Pregnancy.
- Comorbidity that makes study participation and completion impossible.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Hypomagnesemia
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Intervention(s)
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Drug: Placebo
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Drug: Mablet 360 mg
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Primary Outcome(s)
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Intracellular magnesium
[Time Frame: 8 weeks]
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Secondary Outcome(s)
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Ionized serum magnesium
[Time Frame: 8 weeks]
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Total serum magnesium
[Time Frame: 8 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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