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

This study has been completed.
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital Identifier:
First received: April 27, 2010
Last updated: September 4, 2013
Last verified: September 2013
To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

Condition Intervention Phase
Chronic Kidney Disease Drug: Zemplar Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Jonas Spaak, Danderyd Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 36
Study Start Date: September 2010
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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).

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

Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

  Contacts and Locations
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Please refer to this study by its identifier: NCT01204528

Karolinska Institute at Danderyd University Hospital
Danderyd, Stockholm, Sweden, 18288
Sponsors and Collaborators
Danderyd Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jonas Spaak, MD, PhD, Danderyd Hospital Identifier: NCT01204528     History of Changes
Other Study ID Numbers: VDRA
Study First Received: April 27, 2010
Last Updated: September 4, 2013

Keywords provided by Jonas Spaak, Danderyd Hospital:
Dysfunction in CKD

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on September 21, 2017