Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease
NCT ID: NCT01204528
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
36 participants
INTERVENTIONAL
2010-09-30
2013-07-31
Brief Summary
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Detailed Description
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May 12 weeks of VDRA treatment reduce the pathological sympathetic overactivation associated with moderate kidney disease?
Secondary questions aim to thrown light on how VDRAs can reduce albuminuria and CRP, i.e. does VDRA treatment improve (prespecified statistical analyses):
A) diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness? D) inflammatory activation? E) platelet function and haemostasis? F) levels of antibacterial peptides? G) levels of IGFBP-1 and adiponectin?
Overall design The study is designed as a double-blind, randomised, placebo-controlled trial involving two groups (n=72) of patients: 1) chronic kidney failure (CKD, eGFR 15-59 mL/m2) and 2) chronic kidney failure and concomitant diabetes mellitus (CKD+DM).
It will start with a two-week placebo run-in, followed by randomisation to:
1. Zemplar 1 μg (taken as 1 x 1 μg capsule and one placebo capsule),
2. Zemplar 2 μg (taken as 2 x 1 μg capsules) and
3. placebo (taken as two placebo capsules).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paricalcitol 2 microgram/d
Zemplar
Vitamin D receptor activator (VDRA)
Paricalcitol 1 microgram/d
Zemplar
Vitamin D receptor activator (VDRA)
Placebo
Zemplar
Vitamin D receptor activator (VDRA)
Interventions
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Zemplar
Vitamin D receptor activator (VDRA)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Danderyd Hospital
OTHER
Responsible Party
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Jonas Spaak
MD, PhD
Locations
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Karolinska Institute at Danderyd University Hospital
Danderyd, Stockholm County, Sweden
Countries
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References
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Lundwall K, Mortberg J, Mobarrez F, Jacobson SH, Jorneskog G, Spaak J. Changes in microparticle profiles by vitamin D receptor activation in chronic kidney disease - a randomized trial. BMC Nephrol. 2019 Aug 1;20(1):290. doi: 10.1186/s12882-019-1445-4.
Mansouri L, Lundwall K, Moshfegh A, Jacobson SH, Lundahl J, Spaak J. Vitamin D receptor activation reduces inflammatory cytokines and plasma MicroRNAs in moderate chronic kidney disease - a randomized trial. BMC Nephrol. 2017 May 16;18(1):161. doi: 10.1186/s12882-017-0576-8.
Lundwall K, Jorneskog G, Jacobson SH, Spaak J. Paricalcitol, Microvascular and Endothelial Function in Non-Diabetic Chronic Kidney Disease: A Randomized Trial. Am J Nephrol. 2015;42(4):265-73. doi: 10.1159/000441364. Epub 2015 Oct 24.
Other Identifiers
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VDRA
Identifier Type: -
Identifier Source: org_study_id