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

Chronic Kidney Disease Clinical Trial

— SOLID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204528
• Other study ID #: VDRA
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 27, 2010
• Last updated: September 4, 2013
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Zemplar
Vitamin D receptor activator (VDRA)

Locations

Country	Name	City	State
Sweden	Karolinska Institute at Danderyd University Hospital	Danderyd	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Abbott

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.	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.	Measured after 12 weeks treatment.
Secondary	Microcirculatory function measured by laser doppler methods.	Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.	Measured after 12 weeks treatment.