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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01204528
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : September 5, 2013
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital

April 27, 2010
September 17, 2010
September 5, 2013
September 2010
June 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01204528 on Archive Site
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.
Same as current
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Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease
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
To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

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).
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Kidney Disease
Drug: Zemplar
Vitamin D receptor activator (VDRA)
  • Active Comparator: Paricalcitol 2 microgram/d
    Intervention: Drug: Zemplar
  • Active Comparator: Paricalcitol 1 microgram/d
    Intervention: Drug: Zemplar
  • Placebo Comparator: Placebo
    Intervention: Drug: Zemplar

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Jonas Spaak, Danderyd Hospital
Danderyd Hospital
Not Provided
Danderyd Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP