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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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12 December 2020 |
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Main ID: |
NCT03550534 |
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Date of registration:
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22/05/2018 |
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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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The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia
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Scientific title:
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The Effectiveness and Safety of Calcium Carbonate in Chronic Kidney Disease With Normophosphatemia: A Double Blind, Randomized Controlled Trial |
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Date of first enrolment:
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November 6, 2015 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03550534 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Bella Yunita, 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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Indonesia University |
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Name:
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Maruhum Bonar H. Marbun, 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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Indonesia University |
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Name:
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Cindy Astrella, MD, BMedSci |
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Address:
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Telephone:
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Email:
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Affiliation:
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Indonesia University |
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Name:
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Pringgodigdo Nugroho, 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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Indonesia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Stage 3 or 4 chronic kidney disease patient that visit nephrology or endocrinology
outpatient clinic of dr. Cipto Mangunkusumo Hospital
- Normal level of serum phosphate
- Agreed to join in this study
Exclusion Criteria:
- Subjects with BMI < 18.5 kg/m2 or > 30 kg/m2
- Consume drugs which may interfere bone mineral metabolism
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Diseases
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Intervention(s)
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Drug: Calcium Carbonate
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Drug: Placebo oral capsule
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Primary Outcome(s)
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Serum Fibroblast Growth Factor 23 (FGF-23)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Serum Calcium Level
[Time Frame: 12 weeks]
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Secondary ID(s)
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198/UN2.F1/ETIK/2015
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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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