Clinical trial NCT01204528: Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease
Official title: Diastolic Dysfunction, Microcirculation Disturbance, Sympathetic Activation and Inflammation in Moderate Kidney Failure and in Diabetic Nephropathy: Disease Modification With Vitamin-D Receptor Activation. A Double-blind, Placebo-controlled, Randomised Trial - the SOLID Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease
Keywords: Dysfunction in CKD
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2010-09-17
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

Detailed description: Main question:

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).

Eligibility criteria: Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

Primary outcomes:
measure: A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
timeFrame: Measured after 12 weeks treatment.
Secondary outcomes:
measure: Microcirculatory function measured by laser doppler methods.
timeFrame: Measured after 12 weeks treatment.
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Karolinska Institute at Danderyd University Hospital
state: Stockholm
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.