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Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease (SOLID)

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ClinicalTrials.gov Identifier: NCT01204528
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : September 5, 2013
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Zemplar Phase 2 Phase 3

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Paricalcitol 2 microgram/d Drug: Zemplar
Vitamin D receptor activator (VDRA)
Active Comparator: Paricalcitol 1 microgram/d Drug: Zemplar
Vitamin D receptor activator (VDRA)
Placebo Comparator: Placebo Drug: Zemplar
Vitamin D receptor activator (VDRA)


Outcome Measures
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Primary Outcome Measures :
  1. A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography. [ Time Frame: Measured after 12 weeks treatment. ]
    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 :
  1. Microcirculatory function measured by laser doppler methods. [ Time Frame: Measured after 12 weeks treatment. ]
    Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204528


Locations
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Sweden
Karolinska Institute at Danderyd University Hospital
Danderyd, Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jonas Spaak, MD, PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01204528    
Other Study ID Numbers: VDRA
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013
Keywords provided by Jonas Spaak, Danderyd Hospital:
Dysfunction in CKD
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency