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

• Sponsor: Danderyd Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01204528
• Collaborator: Abbott (Industry)
• Enrollment: 36
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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):

1. diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness?
2. 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

• Study Type: Interventional
• 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: Sep 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

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

Primary Outcome Measures

1. A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography. [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. [Measured after 12 weeks treatment.]

   Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institute at Danderyd University Hospital	Danderyd	Stockholm	Sweden	18288

Sponsors and Collaborators

• Danderyd Hospital
• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonas Spaak, MD, PhD, Danderyd Hospital
• ClinicalTrials.gov Identifier: NCT01204528
• Other Study ID Numbers: VDRA
• First Posted: Sep 17, 2010
• Last Update Posted: Sep 5, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Jonas Spaak, MD, PhD, Danderyd Hospital: Dysfunction in CKD
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic

Study Results

No Results Posted as of Sep 5, 2013