Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease (SOLID)
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Zemplar
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Dysfunction in CKD
Eligibility Criteria
Inclusion Criteria:
eGFR 15-59 ml/m2
Exclusion Criteria:
Current vitamin D treatment
Sites / Locations
- Karolinska Institute at Danderyd University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Paricalcitol 2 microgram/d
Paricalcitol 1 microgram/d
Placebo
Arm Description
Outcomes
Primary Outcome Measures
A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
Sympathetic activation is closely related to severity and progression of cardiovascular diseases, and renovascular dysfunction. We will directly measure sympathetic activation using microneurography (muscle sympathetic nerve activity; MSNA), expressed as bursts/minute and bursts/100 RR-interval. As this is a physiological study, the primary outcome will constitute a significant reduction in MSNA.
Secondary Outcome Measures
Microcirculatory function measured by laser doppler methods.
Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.
Full Information
NCT ID
NCT01204528
First Posted
April 27, 2010
Last Updated
September 4, 2013
Sponsor
Danderyd Hospital
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01204528
Brief Title
Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease
Acronym
SOLID
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Zemplar 1 μg (taken as 1 x 1 μg capsule and one placebo capsule),
Zemplar 2 μg (taken as 2 x 1 μg capsules) and
placebo (taken as two placebo capsules).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Dysfunction in CKD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paricalcitol 2 microgram/d
Arm Type
Active Comparator
Arm Title
Paricalcitol 1 microgram/d
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zemplar
Intervention Description
Vitamin D receptor activator (VDRA)
Primary Outcome Measure Information:
Title
A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.
Description
Sympathetic activation is closely related to severity and progression of cardiovascular diseases, and renovascular dysfunction. We will directly measure sympathetic activation using microneurography (muscle sympathetic nerve activity; MSNA), expressed as bursts/minute and bursts/100 RR-interval. As this is a physiological study, the primary outcome will constitute a significant reduction in MSNA.
Time Frame
Measured after 12 weeks treatment.
Secondary Outcome Measure Information:
Title
Microcirculatory function measured by laser doppler methods.
Description
Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.
Time Frame
Measured after 12 weeks treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
eGFR 15-59 ml/m2
Exclusion Criteria:
Current vitamin D treatment
Facility Information:
Facility Name
Karolinska Institute at Danderyd University Hospital
City
Danderyd
State/Province
Stockholm
ZIP/Postal Code
18288
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
31370809
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.
Results Reference
derived
PubMed Identifier
28511692
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.
Results Reference
derived
PubMed Identifier
26496210
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.
Results Reference
derived
Learn more about this trial
Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease
We'll reach out to this number within 24 hrs