Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease

Erling Bjerregaard Pedersen

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Placebo; Drug: Zemplar

Study type: Interventional

Funder types: Other

Identifiers

NCT01136564

2009-017619-14 (EudraCT Number)

EBP-TL-2010

Details and patient eligibility

About

Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney disease corresponding to eGFR: 15-59 ml/min
• Albuminuria > 30 mg/l

Exclusion criteria

• Total parathyroidectomy
• Diabetes Mellitus
• Cancer
• Illicit drug or alcohol abuse
• Pregnancy og nursing
• Ongoing NSAID or corticosteroid treatment
• b-hemoglobin < 6 mmol/l
• p-albumin < 25 mmol/l
• Clinically significant hypercalcemia
• Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Paricalcitol

Active Comparator group

Treatment:

Drug: Zemplar

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo