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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01204528
First received: April 27, 2010
Last updated: September 4, 2013
Last verified: September 2013

April 27, 2010
September 4, 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. ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Microcirculatory function measured by laser doppler methods. [ Time Frame: Measured after 12 weeks treatment. ] [ Designated as safety issue: No ]
Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.
Same as current
Not Provided
Not Provided
 
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).
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
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

Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01204528
VDRA
Yes
Jonas Spaak, Danderyd Hospital
Danderyd Hospital
Abbott
Not Provided
Danderyd Hospital
September 2013

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