Clinical trial NCT01136564: Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease
Official title: Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: paricalcitol
vitamin d
kidney disease
renin
proteinuria
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2010-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: plasma renin concentration
timeFrame: 6 weeks
Secondary outcomes:
measure: Urinary albumin excretion
timeFrame: 6 weeks
measure: GFR
timeFrame: 6 weeks
measure: Fractional excretion of sodium
timeFrame: 6 weeks
measure: Urinary excretion of aquaporin-2
timeFrame: 6 weeks
measure: Urinary excretion of ENaC-beta
timeFrame: 6 weeks
measure: Urinary excretion of NCC
timeFrame: 6 weeks
measure: Plasma concentration of aldosterone
timeFrame: 6 weeks
measure: Plasma concentration of angiotensin-II
timeFrame: 6 weeks
measure: Plasma concentration of ADH
timeFrame: 6 weeks
measure: Plasma concentration of atrial natriuretic peptide
timeFrame: 6 weeks
measure: Plasma concentration of brain natriuretic peptide
timeFrame: 6 weeks
measure: Plasma concentration of endothelin
timeFrame: 6 weeks
measure: 24-hr ambulatory blood pressure
timeFrame: 6 weeks
measure: Central blood pressure
timeFrame: 6 weeks
measure: Pulse wave velocity
timeFrame: 6 weeks
measure: augmentation index
timeFrame: 6 weeks
measure: Plasma concentration of ionized calcium
timeFrame: 6 weeks
measure: Plasma concentration of phosphate
timeFrame: 6 weeks
measure: Plasma concentration of alkaline phosphatase
timeFrame: 6 weeks
measure: Plasma concentration of Parathyroid hormon
timeFrame: 6 weeks
measure: Plasma concentration of 25-hydroxy-vitamin D
timeFrame: 6 weeks
measure: Plasma concentration of ultrasensitive CRP
timeFrame: 6 weeks
measure: Plasma concentration of TNF-alpha
timeFrame: 6 weeks
measure: Plasma concentration of TGF-beta
timeFrame: 6 weeks
measure: Urinary excretion of calcium
timeFrame: 6 weeks
measure: Plasma concentration of ADMA
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medical Research
Study officials:
affiliation: Department of Medical Research
name: Erling B Pedersen, Prof, MSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen T, Mose FH, Bech JN, Pedersen EB. Effect of paricalcitol on renin and albuminuria in non-diabetic stage III-IV chronic kidney disease: a randomized placebo-controlled trial. BMC Nephrol. 2013 Jul 26;14:163. doi: 10.1186/1471-2369-14-163.