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Completed

NCT Number: NCT01204528

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

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

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Karolinska Institute at Danderyd University Hospital

Danderyd, Stockholm County, 18288, Sweden

About this study

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:

  • Zemplar 1 μg (taken as 1 x 1 μg capsule and one placebo capsule),
  • Zemplar 2 μg (taken as 2 x 1 μg capsules) and
  • placebo (taken as two placebo capsules).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

eGFR 15-59 ml/m2

Exclusion criteria

Current vitamin D treatment

Treatment and study plan

Zemplar

Drug

Vitamin D receptor activator (VDRA)

Primary outcomes

  1. A significant reduction in muscle sympathetic nerve activity (MSNA) measured by means of microneurography.

    Time frame: 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 outcomes

  1. Microcirculatory function measured by laser doppler methods.

    Time frame: Measured after 12 weeks treatment.

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

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Abbott

Registry information

Official study 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

Acronym: SOLID

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 17, 2010
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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