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

Danderyd Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Zemplar

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01204528

VDRA

Details and patient eligibility

About

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

Full 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).

Enrollment: 36 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

eGFR 15-59 ml/m2

Exclusion criteria

Current vitamin D treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Paricalcitol 2 microgram/d

Active Comparator group

Treatment:

Drug: Zemplar

Paricalcitol 1 microgram/d

Active Comparator group

Treatment:

Drug: Zemplar

Placebo

Placebo Comparator group

Treatment:

Drug: Zemplar