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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01204528

Acronym

SOLID

Enrollment

Registered

2010-09-17

Start date

2010-09-30

Completion date

2013-07-31

Last updated

2013-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Dysfunction in CKD

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).

Interventions

DRUGZemplar

Vitamin D receptor activator (VDRA)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

eGFR 15-59 ml/m2

Exclusion criteria

Current vitamin D treatment

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026