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

Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01136564

Enrollment

Registered

2010-06-03

Start date

2010-07-31

Completion date

2011-12-31

Last updated

2012-01-25

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

Conditions

Chronic Kidney Disease

Keywords

paricalcitol, vitamin d, kidney disease, renin, proteinuria

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.

Interventions

DRUGZemplar

2 capsules of 1 microgram daily

DRUGPlacebo

2 capsules daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
plasma renin concentration	6 weeks

Secondary

Measure	Time frame
GFR	6 weeks
Fractional excretion of sodium	6 weeks
Urinary excretion of aquaporin-2	6 weeks
Urinary excretion of ENaC-beta	6 weeks
Urinary excretion of NCC	6 weeks
Plasma concentration of aldosterone	6 weeks
Plasma concentration of angiotensin-II	6 weeks
Plasma concentration of ADH	6 weeks
Plasma concentration of atrial natriuretic peptide	6 weeks
Plasma concentration of brain natriuretic peptide	6 weeks
Plasma concentration of endothelin	6 weeks
24-hr ambulatory blood pressure	6 weeks
Urinary albumin excretion	6 weeks
Pulse wave velocity	6 weeks
augmentation index	6 weeks
Plasma concentration of ionized calcium	6 weeks
Plasma concentration of phosphate	6 weeks
Plasma concentration of alkaline phosphatase	6 weeks
Plasma concentration of Parathyroid hormon	6 weeks
Plasma concentration of 25-hydroxy-vitamin D	6 weeks
Plasma concentration of ultrasensitive CRP	6 weeks
Plasma concentration of TNF-alpha	6 weeks
Plasma concentration of TGF-beta	6 weeks
Urinary excretion of calcium	6 weeks
Plasma concentration of ADMA	6 weeks
Central blood pressure	6 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026