NCT01204528

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Danderyd Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Zemplar	Vitamin D receptor activator (VDRA)

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2010-09-17
• Last updated: 2013-09-05

Locations

1 site across 1 country: Sweden