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

Phase 2

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Zemplar

• Registration Number: NCT01204528
• Lead Sponsor: Danderyd Hospital

Brief 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).

Study Timeline

• Study First Submitted: 2010-04-27
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-16
• Study First Posted: 2010-09-17
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

eGFR 15-59 ml/m2

Exclusion Criteria

Current vitamin D treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paricalcitol 2 microgram/d	Zemplar	-
Placebo	Zemplar	-
Paricalcitol 1 microgram/d	Zemplar	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Microcirculatory function measured by laser doppler methods.	Measured after 12 weeks treatment.	Assessed by skin laser-doppler methodology, and directly by nailfold capillaroscopy.

Trial Locations

Locations (1)

Karolinska Institute at Danderyd University Hospital; 🇸🇪 Danderyd, Stockholm, Sweden