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

This study is currently recruiting participants.
Verified April 2013 by Danderyd Hospital
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Jonas Spaak, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT01204528
First received: April 27, 2010
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by 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. ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 72
Study Start Date: September 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: May 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).
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

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

Contacts
Contact: Jonas Spaak, MD, PhD +46 7602014178 jonas.spaak@ki.se

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

No publications provided

Responsible Party: Jonas Spaak, MD, PhD, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01204528     History of Changes
Other Study ID Numbers: VDRA
Study First Received: April 27, 2010
Last Updated: April 25, 2013
Health Authority: Medical Products Agency of Sweden through the EudraCT programme. Protocol Nr: 2007-006274-29

Keywords provided by Danderyd Hospital:
Dysfunction in CKD

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Renal Insufficiency
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013